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Key Points 
  
 Question What is the effectiveness of a scalp cooling device in preventing alopecia in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy? 
  
 Findings In a randomized clinical trial of 182 women with breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have less than 50% hair loss compared with no scalp cooling (50.5% vs 0%). The trial was stopped early for superiority, and there was no effect on measures of quality of life. 
  
 Meaning This scalp cooling system was more likely to prevent alopecia than no treatment, and further research is needed to assess longer-term efficacy and adverse effects. 
  
 Abstract 
  
 Importance Chemotherapy may induce alopecia. Although scalp cooling devices have been used to prevent this alopecia, efficacy has not been assessed in a randomized clinical trial. 
  
 Objectives To assess whether a scalp cooling device is effective at reducing chemotherapy-induced alopecia and to assess adverse treatment effects. 
  
 Design, Setting, and Participants Multicenter randomized clinical trial of women with breast cancer undergoing chemotherapy. Patients were enrolled from December 9, 2013, to September 30, 2016. One interim analysis was planned to allow the study to stop early for efficacy. Data reported are from the interim analysis. This study was conducted at 7 sites in the United States, and 182 women with breast cancer requiring chemotherapy were enrolled and randomized. 
  
 Interventions Participants were randomized to scalp cooling (n = 119) or control (n = 63). Scalp cooling was done using a scalp cooling device. 
  
 Main Outcomes and Measures The primary efficacy end points were successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade 0 [no hair loss] or grade 1 [<50% hair loss not requiring a wig] were considered to have hair preservation) at the end of 4 cycles of chemotherapy by a clinician unaware of treatment assignment, and device safety. Secondary end points included wig use and scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30, Hospital Anxiety and Depression Scale, and a summary scale of the Body Image Scale. 
  
 Results At the time of the interim analysis, 142 participants were evaluable. The mean (SD) age of the patients was 52.6 (10.1) years; 36% (n = 51) received anthracycline-based chemotherapy and 64% (n = 91) received taxane-based chemotherapy. Successful hair preservation was found in 48 of 95 women with cooling (50.5%; 95% CI, 40.7%-60.4%) compared with 0 of 47 women in the control group (0%; 95% CI, 0%-7.6%) (success rate difference, 50.5%; 95% CI, 40.5%-60.6%). Because the 1-tailed P value from the Fisher exact test was <.001, which crossed the superiority boundary (P = .0061), the data and safety monitoring board recommended study termination on September 26, 2016. There were no statistically significant differences in changes in any of the scales of quality of life from baseline to chemotherapy cycle 4 among the scalp cooling and control groups. Only adverse events related to device use were collected; 54 adverse events were reported in the cooling group, all grades 1 and 2. There were no serious adverse device events. 
  
 Conclusions and Relevance Among women with stage I to II breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have less than 50% hair loss after the fourth chemotherapy cycle compared with those who received no scalp cooling. Further research is needed to assess longer-term efficacy and adverse effects. 
  
 Trial Registration clinicaltrials.gov Identifier: NCT01986140 ||||| Cooling Cap May Limit Chemo Hair Loss In Women With Breast Cancer 
  
 Enlarge this image toggle caption Courtesy of Baylor College of Medicine Courtesy of Baylor College of Medicine 
  
 It's no surprise that most women with breast cancer consider hair loss one of the most traumatic aspects of chemotherapy. That has led to a big market for cooling caps, which are purported to limit hair loss. 
  
 But cooling caps haven't been extensively studied in the U.S., and womens' experiences with the caps have been hit or miss. And just one cooling cap, the DigniCap, is approved by the Food and Drug Administration. 
  
 Two studies released Tuesday show that at least half the women who used either the DigniCap or another scalp cooling system, the Paxman, lost less than 50 percent of their hair. 
  
 "These findings appear to represent a major step forward in improving the quality of life of individuals with cancer," says Dr. Dawn Hershman, who studies the effects of cancer treatments at the Columbia University School of Medicine in New York. She wrote an editorial accompanying the studies in JAMA, the journal of the American Medical Association. 
  
 But Hershman cautions that more study is needed to determine whether there is psychological benefit in using the caps to prevent hair loss. 
  
 And the cost and who will pay for the treatment are also issues, she says. The average cost is $1,500 to $3,000, depending on the number of chemotherapy cycles. 
  
 In the DigniCap study, 67 of 106 women (66.3 percent) lost less than half their hair after four rounds of taxane chemotherapy. The women had either stage I or II breast cancer. 
  
 In contrast, all of the 16 women who did not use the cap lost all of their hair during chemotherapy. 
  
 The DigniCap system uses a double cap fitted to the scalp 30 minutes before an infusion, which keeps the scalp at 37 degrees Fahrenheit, plus or minus 2 degrees, during the session. The system was approved by the FDA in 2015 and is available at infusion centers in 17 states. 
  
 The other study found similar results using the Paxman system. It was led by oncologist Julie Nangia of the Baylor College of Medicine in Houston. 
  
 Enlarge this image toggle caption Courtesy of Baylor College of Medicine Courtesy of Baylor College of Medicine 
  
 Half of the 95 women (50.5 percent) using the Paxman system lost less than half their hair after four rounds of anthracycline and taxane chemotherapy, including five women who had no significant hair loss, as judged by independent observers from photographs. 
  
 Among the 47 who did not use the cooling system, all lost all of their hair. 
  
 The Paxman study was stopped earlier than planned, after four cycles of chemotherapy, because findings showed the cooling cap was highly effective at preventing hair loss. That cooling system is not yet available commercially in the U.S. and is under review at the FDA. 
  
 "It's nice now to have two good studies focusing on the quality of life to make the cancer journey easier for women," Nangia tells NPR. 
  
 There were no serious side effects related to either cooler. A few people reported headaches, and some stopped using the device because they got too cold. Nangia says most patients described the device as "reasonably comfortable." 
  
 The studies were funded and designed, in part, by their respective manufacturers, with varying levels of company input to the university investigators. In both cases, the researchers were free to publish results they deemed appropriate. 
  
 Researchers don't know exactly how the cooling caps work. One theory is that cooling constricts the blood vessels in the scalp, slowing the circulation and thereby reducing the amount of toxins to which hair follicles are exposed. 
  
 Or it may be that cold slows the growth of hair follicles, making them less susceptible to damage from chemotherapy, which targets rapidly dividing cells. 
  
 Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, says it could be that "by slowing down those cells whatever mechanism it may be — either starving their blood flow or slowing them down straightforwardly — the net effect is beneficial, causing hair not to fall out." 
  
 While chilling the scalp may seem to carry few risks, Lichtenfeld says there is a theoretical risk that inhibiting the effect of chemotherapy in the scalp could allow metastases to take hold there. 
  
 "These techniques are relatively new," he says, and "breast cancer is a disease that can take a long time before it comes back and if one is to be 100 percent certain then you need a long period of time to answer the question." 
  
 So far, cancer recurrence on the scalp has not been seen in the U.S. studies, but authors of both JAMA papers say longer follow-up is needed to be sure that this is not a risk. ||||| TUESDAY, Feb. 14, 2017 -- Scalp cooling caps can help breast cancer patients save their hair from the ravages of chemotherapy, a pair of new studies suggests. 
  
 More than half of women fitted with cooling caps kept their hair during chemotherapy in the world's first randomized clinical trial of the devices, said lead researcher Dr. Julie Nangia. She is an assistant professor and breast cancer expert with the Baylor College of Medicine in Houston. 
  
 "The trial was stopped early because the device was so effective in the group that got the device," Nangia said. "In our study, half of women who used the scalp cooling device kept their hair, and in the control group there was zero percent hair retention. Everyone who didn't have the device lost their hair." 
  
 A second study also found that the cooling caps could reduce hair loss, with two-thirds of patients losing half or less of their hair during chemotherapy, researchers reported. 
  
 The studies were published Tuesday in the Journal of the American Medical Association. Both received funding from the makers of the cooling devices used in each study, Paxman Coolers of England and Dignitana of Sweden, respectively. 
  
 Scalp cooling caps could help save lives by making chemotherapy more acceptable to breast cancer patients, Nangia said. 
  
 About 50 percent of patients consider hair loss the most traumatic aspect of chemotherapy, and about 8 percent report they would decline chemo because of this concern, an accompanying journal editorial stated. 
  
 "Universally, every woman cries when I tell them they're going to lose their hair. There's a very emotional aspect to it," Nangia said. 
  
 "When you lose your hair, that's part of your body image and your sexuality," she continued. "You also lose your anonymity and privacy. Everybody knows you are sick. You can't just go out and be a normal person." 
  
 The harsh drugs used in chemotherapy cause hair follicles to become weak and break. They also damage hair growth cells in follicles, which can stop the hair growth cycle altogether or cause new hair to shed easily. 
  
 Scalp cooling caps appear to limit this damage by constricting blood vessels in the scalp, reducing the amount of chemo that is delivered to the hair follicles, Nangia explained. The cooling caps also might decrease the biochemical damage done to follicles by whatever chemo does get through. 
  
 Patients put on a tight scalp cooling cap for a half-hour before chemotherapy, and leave it on for 90 minutes to 120 minutes afterward, according to the two studies. 
  
 "The key is to have a tight fit, because if you have any gaps you'll lose hair where there's not good contact," Nangia said. 
  
 Nangia's clinical trial included 182 breast cancer patients. Two-thirds were randomly chosen to receive scalp cooling, and the rest received chemotherapy without a cooling cap. 
  
 However, the trial was halted after data came in for the first 142 patients and it became clear that cooling had a significant effect in slowing or stopping hair loss, Nangia said. 
  
 The second study, conducted at five U.S. medical centers and led by Dr. Hope Rugo from the University of California, San Francisco, involved 101 breast cancer patients fitted with a cooling cap and 16 patients in a control group. Again, all patients without the cap lost their hair, while hair loss was limited or halted in those who used the scalp cooling cap. 
  
 The risk of hair loss varied widely in both studies, depending on which medical center provided the scalp cooling therapy and which chemo drugs were used in treatment, said Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society. He was not involved with the research. 
  
 The amount of experience a center had with the devices appeared to improve their ability to preserve hair, and the relative harshness of the patient's chemotherapy also seemed to play a role, Lichtenfeld explained. 
  
 "These devices do prevent hair loss in some women, but it's very much operator-dependent and chemotherapy-dependent," Lichtenfeld said. 
  
 Scalp cooling devices cost between $1,500 and $3,000 per patient in the United States, and aren't reimbursed by health insurance, Nangia's study noted. That's not counting the time and cost of applying the device during chemo, Lichtenfeld added. 
  
 Neither study found any short-term adverse effects caused by the cooling caps. But, there are worries that cancer might reappear in a woman's scalp years after treatment, said Lichtenfeld and Dr. Richard Bleicher, breast clinical service line leader with Fox Chase Cancer Center in Philadelphia. 
  
 Bleicher, who's also an associate professor of surgical oncology at Fox Chase, said that "there has been some concern that if less chemotherapy circulates to the scalp, breast cancer metastases could have a greater likelihood of occurring there." 
  
 Nangia acknowledged concerns that restricting flow of chemo to the scalp could protect cancer cells hiding there. 
  
 Both research teams plan to follow patients for at least five years to see if there's any increased risk for cancer recurrence. Nangia added that previous European studies have found no effect on long-term cancer survival. 
  
 For more about scalp cooling, visit the American Cancer Society. 
  
 Copyright © 2017 HealthDay. All rights reserved. 
  
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– Cooling caps are massively popular with European chemo patients and have been making inroads into the US, but two studies published Tuesday in the Journal of the American Medical Association offer some of the first clinical proof of their effectiveness. In one study, approximately two-thirds of breast cancer patients lost less than half their hair; in the other study, approximately half of breast cancer patients lost less than half their hair. The New York Times reports 5% of patients kept all their hair. The differences in effectiveness between the studies could have to do with the cooling caps being used, the medical centers applying the caps, and the chemo drugs involved, according to HealthDay News. The studies were funded by two different companies that manufacture cooling caps. Cooling caps are affixed to patients' heads before, during, and after chemo; a machine cycles cooling liquid through the caps. While researchers aren't exactly sure how the caps prevent hair loss, NPR reports, one theory is they restrict blood vessels in the scalp, reducing the amount of chemo that reaches the hair follicles. About half of breast cancer patients say hair loss is the most daunting part of chemo, and 8% say they would turn down chemo in order to keep their hair. One breast cancer survivor who used a cooling cap says it has psychological benefits. She tells the Times that losing their hair makes people "think they're sicker than they actually are." (A dose of magic mushrooms had a big effect on cancer patients.)
Skriv en sammanfattning baserad på denna artikel: Nyckelpunkter Fråga Vad är effektiviteten hos en skalpera kylapparat för att förhindra alopeci hos kvinnor med bröstcancer som genomgår neoadjuvant eller adjuvant kemoterapi? Resultat I en randomiserad klinisk studie på 182 kvinnor med bröstcancer som fick kemoterapi med ett taxan, antracyklin eller båda, var sannolikheten för att de som genomgick skalpkylning signifikant större att få mindre än 50% håravfall jämfört med ingen skalpkylning (50, 5% mot 0%). Rättegången stoppades tidigt för överlägsenhet, och det blev ingen effekt på mått på livskvalitet. Innebörd Detta skalpkylningssystem var mer sannolikt att förhindra alopeci än ingen behandling, och ytterligare forskning behövs för att bedöma långsiktig effekt och biverkningar. Abstrakt Betydelse Kemoterapi kan framkalla alopeci. Även om skalpkylningsanordningar har använts för att förhindra denna alopeci, har effekten inte utvärderats i en randomiserad klinisk prövning. Mål Att bedöma om en skalpkylningsanordning är effektiv för att minska kemoterapiinducerad alopeci och för att bedöma biverkningar. Design, Setting och Deltagare Multicenter randomiserade kliniska prövningar av kvinnor med bröstcancer som genomgår kemoterapi. Patienterna rekryterades från 9 december 2013, till 30 september 2016. En interimsanalys planerades för att studien skulle kunna avslutas tidigt för effekt. Data som rapporteras kommer från interimsanalysen. Denna studie genomfördes på 7 platser i USA, och 182 kvinnor med bröstcancer som behövde kemoterapi rekryterades och randomiserades. Interventioner Deltagarna randomiserades till skalpkylning (n = 119) eller kontroll (n = 63). Skalpkylning gjordes med hjälp av en skalpkylningsanordning. Huvudresultat och mått De primära effektmåtten var framgångsrikt hårbevarande som bedömdes med hjälp av de gemensamma terminologiska kriterierna för biverkningar version 4.0-skalan (grad 0 [inget håravfall] eller grad 1 [< 50 % håravfall som inte kräver en peruk] ansågs ha hårbevarande) i slutet av 4 cykler kemoterapi av en kliniker som var omedveten om behandlingsuppdrag, och säkerhet för enheten. Sekundära slutpunkter var perukanvändning och poäng på Europeiska organisationen för forskning och behandling av cancerkvalitet Frågeformulär–Core 30, sjukhusångest och depression Skala, och en sammanfattande skala av Body Image Scale. Resultat Vid tiden för interimsanalysen var 142 deltagare utvärderbara. Patienternas medelålder (SD) var 52,6 (10,1) år; 36 % (n = 51) fick antracyklinbaserad kemoterapi och 64 % (n = 91) fick taxanbaserad kemoterapi. Framgångsrik hårbevarande sågs hos 48 av 95 kvinnor med kylning (50,5 %; 95 % KI, 40,7 %-60,4 %) jämfört med 0 av 47 kvinnor i kontrollgruppen (0 %; 95 % KI, 0 %-7,6 %) (framgångsmässig skillnad, 50,5 %; 95 % KI, 40,5 %-60,6 %). Eftersom det 1-svansade P-värdet från Fishers exakta test var < .001, vilket gick över överlägsenhetsgränsen (P = .0061), rekommenderade data- och säkerhetsövervakningsnämnden att studien skulle avslutas den 26 september 2016. Det fanns inga statistiskt signifikanta skillnader i förändringar i någon av livskvalitetsskalorna från baslinje till kemoterapicykel 4 i skalpkylnings - och kontrollgrupperna. Endast biverkningar relaterade till användning av en produkt samlades in; 54 biverkningar rapporterades i kylgruppen, alla grad 1 och 2. Det förekom inga allvarliga biverkningar. Slutsatser och relevans Bland kvinnor med stadium I till II bröstcancer som fick kemoterapi med en taxan, antracyklin, eller båda, var de som genomgick hårbotten kylning signifikant mer sannolikt att ha mindre än 50% håravfall efter den fjärde kemoterapicykeln jämfört med de som inte fick någon hårbotten kylning. Det behövs ytterligare forskning för att bedöma effekt och negativa effekter på längre sikt. Trial Registration clinicaltrials.gov Identifier: NCT01986140 â € Cooling Cap Kan Begränsa Chemo Håravfall hos kvinnor med bröstcancer Förstora denna bild toggle bildtext Genom tillmötesgående från Baylor College of Medicine Genom tillmötesgående från Baylor College of Medicine Det är ingen överraskning att de flesta kvinnor med bröstcancer anser håravfall en av de mest traumatiska aspekterna av kemoterapi. Det har lett till en stor marknad för kyllock, som påstås begränsa håravfallet. Men kylmössor har inte studerats ingående i USA, och kvinnors erfarenheter av mössorna har träffats eller missats. Och bara en kylmössa, DigniCap, är godkänd av Food and Drug Administration. Två studier som släpptes på tisdag visar att minst hälften av de kvinnor som använde antingen DigniCap eller ett annat system för skalperkylning, Paxman, förlorade mindre än 50 procent av sitt hår. "Dessa resultat verkar vara ett stort steg framåt för att förbättra livskvaliteten för personer med cancer", säger Dr. Dawn Hershman, som studerar effekterna av cancerbehandlingar vid Columbia University School of Medicine i New York. Hon skrev en ledarartikel som åtföljde studierna i JAMA, American Medical Associations tidskrift. Men Hershman varnar för att det behövs mer studier för att avgöra om det finns psykologisk nytta med att använda mössorna för att förhindra håravfall. Och kostnaden och vem som ska betala för behandlingen är också problem, säger hon. Den genomsnittliga kostnaden är $ 1500 till $ 3.000, beroende på antalet kemoterapi cykler. I DigniCap-studien förlorade 67 av 106 kvinnor (66,3 procent) mindre än halva håret efter fyra omgångar av taxankemoterapi. Kvinnorna hade antingen stadium I eller II bröstcancer. Däremot förlorade alla de 16 kvinnor som inte använde locket allt hår under kemoterapin. DigniCap-systemet använder en dubbel hätta monterad på hårbotten 30 minuter före en infusion, som håller hårbotten på 37 grader Fahrenheit, plus eller minus 2 grader, under sessionen. Systemet godkändes av FDA 2015 och finns på infusionscentraler i 17 delstater. I den andra studien fann man liknande resultat med hjälp av Paxman-systemet. Den leddes av onkologen Julie Nangia vid Baylor College of Medicine i Houston. Förstora denna bild toggle bildtext Genom tillmötesgående från Baylor College of Medicine Genom tillmötesgående från Baylor College of Medicine Hälften av de 95 kvinnor (50,5 procent) som använder Paxman systemet förlorade mindre än hälften av sitt hår efter fyra omgångar av antracyklin och taxan kemoterapi, inklusive fem kvinnor som inte hade något betydande håravfall, som bedöms av oberoende observatörer från fotografier. Bland de 47 som inte använde kylsystemet förlorade alla sitt hår. Paxman-studien avbröts tidigare än planerat, efter fyra kemoterapicykler, eftersom fynden visade att kyllocket var mycket effektivt för att förhindra håravfall. Det kylsystemet finns ännu inte kommersiellt tillgängligt i USA och är under granskning på FDA. "Det är skönt att nu ha två bra studier med fokus på livskvalitet för att underlätta cancerresan för kvinnor", berättar Nangia för NPR. Det fanns inga allvarliga biverkningar relaterade till någon av kylarna. Några rapporterade huvudvärk, och några slutade använda apparaten eftersom de blev för kalla. Nangia säger att de flesta patienter beskrev apparaten som "rimligt bekväm". Studierna finansierades och utformades delvis av deras respektive tillverkare, med varierande nivåer av företagsinput till universitetsutredarna. I båda fallen var forskarna fria att publicera resultat som de ansåg lämpliga. Forskare vet inte exakt hur kyllocken fungerar. En teori är att kylningen drar ihop blodkärlen i hårbotten, vilket saktar ner cirkulationen och därmed minskar mängden gifter som hårsäckarna utsätts för. Eller också kan det vara så att kylan saktar ner hårsäckarnas tillväxt, vilket gör dem mindre känsliga för skador från kemoterapi, som riktar sig mot snabbt delande celler. Doktor Len Lichtenfeld, ställföreträdande chefsläkare vid American Cancer Society, säger att det kan vara så att "genom att sakta ner dessa celler vilken mekanism det än kan vara — antingen svälta deras blodflöde eller sakta ner dem rättframt — är nettoeffekten fördelaktig, vilket får håret att inte falla ut." Medan kyla hårbotten kan tyckas bära få risker, Lichtenfeld säger att det finns en teoretisk risk att hämma effekten av kemoterapi i hårbotten kan tillåta metastaser att ta tag där. "Dessa tekniker är relativt nya", säger han, och "bröstcancer är en sjukdom som kan ta lång tid innan den kommer tillbaka och om man ska vara 100 procent säker så behöver man en lång tid för att svara på frågan." Hittills har cancer återfall i hårbotten inte setts i USA studier, men författare av båda JAMA tidningar säger längre uppföljning behövs för att vara säker på att detta inte är en risk. TISDAG 14 februari 2017 -- Skalpkylskåpor kan hjälpa bröstcancer patienter att rädda sitt hår från härjningar av kemoterapi, ett par nya studier tyder. Mer än hälften av kvinnorna med kyllock behöll sitt hår under kemoterapin i världens första randomiserade kliniska prövning av apparaterna, sade leda forskaren Dr Julie Nangia. Hon är biträdande professor och bröstcancerexpert vid Baylor College of Medicine i Houston. "Protesten stoppades tidigt eftersom enheten var så effektiv i gruppen som fick apparaten", sa Nangia. "I vår studie behöll hälften av de kvinnor som använde skalpkylningsapparaten sitt hår, och i kontrollgruppen var det noll procent hårretention. Alla som inte hade apparaten tappade håret." En andra studie visade också att kyllocken kunde minska håravfallet, med två tredjedelar av patienterna förlorar hälften eller mindre av sitt hår under kemoterapi, rapporterade forskare. Studierna publicerades tisdagen i Journal of the American Medical Association. Båda fick finansiering från tillverkarna av de kylaggregat som användes i varje studie, Paxman Coolers of England respektive Dignitana of Sweden. Skalpkylskåpor kan hjälpa till att rädda liv genom att göra kemoterapi mer acceptabel för bröstcancerpatienter, sade Nangia. Omkring 50 procent av patienterna anser att håravfall är den mest traumatiska aspekten av kemoterapi, och omkring 8 procent rapporterar att de skulle minska cellgifterna på grund av denna oro, uppgav en medföljande tidskriftsredaktion. "Varje kvinna gråter när jag säger att de kommer att tappa håret. Det finns en mycket känslomässig aspekt av det," Nangia sade. "När du tappar håret är det en del av din kroppsbild och din sexualitet", fortsatte hon. "Du förlorar också din anonymitet och integritet. Alla vet att du är sjuk. Du kan inte bara gå ut och vara en normal människa." De hårda läkemedel som används vid kemoterapi gör att hårsäckarna blir svaga och går sönder. De skadar också hårväxtceller i folliklar, som kan stoppa hårväxtcykeln helt eller få nytt hår att lätt fällas. Skalpkylskåpor verkar begränsa denna skada genom att dra ihop blodkärlen i hårbotten, vilket minskar mängden cellgifter som levereras till hårsäckarna, förklarade Nangia. Kyllocken kan också minska den biokemiska skada som folliklarna orsakar genom vad cellgifterna än tar sig igenom. Patienterna sätter på sig en snäv kylhatt i en halvtimme före kemoterapin och låter den vara på 90 minuter till 120 minuter efteråt, enligt de två studierna. "Nyckeln är att ha en tät passform, för om du har några luckor kommer du att tappa hår där det inte finns någon bra kontakt," Nangia sade. Nangias kliniska prövning omfattade 182 bröstcancerpatienter. Två tredjedelar valdes slumpmässigt för att få skalpkylning, och resten fick kemoterapi utan kyllock. Studien stoppades dock efter att data kom in för de första 142 patienterna och det stod klart att kylning hade en betydande effekt för att sakta ner eller stoppa håravfallet, sade Nangia. Den andra studien, som genomfördes vid fem medicinska center i USA och leddes av dr Hope Rugo från University of California i San Francisco, omfattade 101 bröstcancerpatienter som hade kylmössa och 16 patienter i en kontrollgrupp. Återigen förlorade alla patienter utan locket håret, medan håravfallet begränsades eller stoppades hos dem som använde skalpen kyllock. Risken för håravfall varierade mycket i båda studierna, beroende på vilken medicinsk centrum tillhandahöll hårbotten kylterapi och vilka kemoläkemedel som användes i behandlingen, sade Dr. Len Lichtenfeld, vice chef medicinsk officer för American Cancer Society. Han var inte inblandad i forskningen. Mängden erfarenhet ett centrum hade med anordningarna verkade förbättra deras förmåga att bevara håret, och den relativa hårdheten i patientens kemoterapi verkade också spela en roll, Lichtenfeld förklarade. "Dessa enheter förhindrar håravfall hos vissa kvinnor, men det är mycket operatörsberoende och kemoterapiberoende," Lichtenfeld sade. Skalpkylaggregat kostar mellan 1500 och 3000 dollar per patient i USA, och ersätts inte av sjukförsäkring, noterade Nangias studie. Det är inte räkna tid och kostnad för att tillämpa enheten under cellgifter, Lichtenfeld tillade. Ingendera studien fann några kortsiktiga biverkningar orsakade av kyllocken. Men, det finns oro för att cancer kan återuppstå i en kvinnas hårbotten år efter behandling, sade Lichtenfeld och Dr Richard Bleicher, bröst klinisk linje ledare med Fox Chase Cancer Center i Philadelphia. Bleicher, som också är docent i kirurgisk onkologi vid Fox Chase, sade att "det har funnits viss oro för att om mindre kemoterapi cirkulerar till hårbotten, skulle bröstcancermetastaser kunna ha en större sannolikhet att inträffa där." Nangia erkände oro över att begränsa flödet av cellgifter till hårbotten skulle kunna skydda cancerceller som gömmer sig där. Båda forskargrupperna planerar att följa patienter i minst fem år för att se om det finns någon ökad risk för återfall i cancer. Nangia tillade att tidigare europeiska studier inte har funnit någon effekt på långsiktig canceröverlevnad. För mer om skalpkylning, besök American Cancer Society. Copyright © 2017 HealthDay. Alla rättigheter förbehållna. Â°°
Write a summary based on this article: Key Points Question What is the effectiveness of a scalp cooling device to prevent alopecia in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy? Results In a randomised clinical study of 182 women with breast cancer receiving chemotherapy with a taxane, anthracycline or both, the likelihood of those undergoing scalp cooling was significantly greater to receive less than 50% hair loss compared to no scalp cooling (50.5% versus 0%). The trial was early halted for superiority, and there was no effect on measures of quality of life. Meaning This scalp cooling system was more likely to prevent alopecia than no treatment, and further research is needed to assess long-term efficacy and side effects. Abstract Importance Chemotherapy may induce alopecia. Although scalp cooling devices have been used to prevent this alopecia, efficacy has not been evaluated in a randomised clinical trial. Objective To assess whether a scalp cooling device is effective in reducing chemotherapy-induced alopecia and in assessing side effects. Design, Setting and Participants Multicenter randomised clinical trials of women with breast cancer undergoing chemotherapy. Patients were recruited from 9 December 2013, to 30 September 2016. An interim analysis was planned for early termination of the study for efficacy. Data reported come from the interim analysis. This study was conducted in 7 locations in the United States, and 182 women with breast cancer who needed chemotherapy were recruited and randomised. Interventions Participants were randomised to scalp cooling (n = 119) or control (n = 63). Scalp cooling was done using a scalp cooling device. Main results and measures The primary endpoints were successful hair preservation assessed using the common terminological criteria for adverse reactions version 4.0 scale (grade 0 [no hair loss] or grade 1 [< 50% hair loss that does not require a wig] was considered to have hair retention) at the end of 4 cycles of chemotherapy by a clinician unaware of treatment missions, and safety of the device. Secondary endpoints were wig use and scores at the European Organization for Cancer Quality Research and Treatment Questionnaire–Core 30, Hospital Anxiety and Depression Scale, and a Summary Scale of Body Image Scale. Results At the time of the interim analysis 142 participants were evaluable. The mean age of patients (SD) was 52.6 (10.1) years; 36% (n = 51) received anthracycline-based chemotherapy and 64% (n = 91) received taxane-based chemotherapy. Successful hair retention was seen in 48 out of 95 women with cooling (50.5%; 95% CI, 40.7%-60.4%) compared to 0 out of 47 women in the control group (0%; 95% CI, 0%-7.6%) (successful difference, 50.5%; 95% CI, 40.5%-60.6%). Since the 1-tailed P-value from Fisher's exact test was < .001, exceeding the superiority limit (P = .0061), the Data and Pharmacovigilance Board recommended that the study be completed on September 26, 2016. There were no statistically significant differences in changes in any of the quality of life scales from baseline to chemotherapy cycle 4 in the scalp cooling and control groups. Only adverse reactions related to the use of a product were collected; 54 adverse reactions were reported in the cooling group, all Grade 1 and 2. There were no serious adverse reactions. Conclusions and relevance Among women with stage I to II breast cancer who received chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have less than 50% hair loss after the fourth cycle of chemotherapy compared to those who did not receive any scalp cooling. Further research is needed to assess long-term impact and negative effects. Trial Registration clinicaltrials.gov Identifier: NCT01986140 â€ Cooling Cap Can Limit Chemo Hair loss in women with breast cancer Enlarge this image toggle caption Courtesy of Baylor College of Medicine Courtesy of Baylor College of Medicine It is no surprise that most women with breast cancer consider hair loss one of the most traumatic aspects of chemotherapy. It has led to a large market for cooling lids, allegedly limiting hair loss. However, cold caps have not been studied extensively in the United States, and women’s experience of the caps has been met or missed. And only a refrigerator cap, DigniCap, is approved by the Food and Drug Administration. Two studies released on Tuesday show that at least half of the women using either DigniCap or another scalp cooling system, Paxman, lost less than 50 percent of their hair. "These results seem to be a major step forward in improving the quality of life for people with cancer," says Dr. Dawn Hershman, who studies the effects of cancer treatments at the Columbia University School of Medicine in New York City. She wrote an editorial accompanying the studies in JAMA, the journal of the American Medical Association. However, Hershman warns that more studies are needed to determine whether there is psychological benefit in using the caps to prevent hair loss. And the cost and who should pay for the treatment is also a problem," she says. The average cost is $1,500 to $3,000, depending on the number of chemotherapy cycles. In the DigniCap study, 67 out of 106 women (66.3%) lost less than half their hair after four rounds of taxane chemotherapy. The women had either stage I or II breast cancer. However, all 16 women who did not use the cap lost all hair during chemotherapy. The DigniCap system uses a double cap mounted on the scalp 30 minutes before an infusion, which keeps the scalp at 37 degrees Fahrenheit, plus or minus 2 degrees, during the session. The system was approved by the FDA in 2015 and is available in infusion centers in 17 states. The second study found similar results using the Paxman system. It was led by oncologist Julie Nangia at Baylor College of Medicine in Houston. Enlarge this image toggle caption Courtesy of Baylor College of Medicine Courtesy of Baylor College of Medicine Half of the 95 women (50.5 percent) using the Paxman system lost less than half of their hair after four rounds of anthracycline and taxane chemotherapy, including five women who had no significant hair loss, assessed by independent observers from photographs. Among the 47 who did not use the cooling system, everyone lost their hair. The Paxman study was discontinued earlier than planned, after four chemotherapy cycles, as findings showed that the cooling cap was very effective in preventing hair loss. That cooling system is not yet commercially available in the United States and is under review at the FDA. "It's good to have two good studies with a focus on quality of life to facilitate the cancer journey for women," Nangia tells NPR. There were no serious side effects related to any of the coolers. Some reported headaches, and some stopped using the device because they became too cold. Nangia says most patients described the device as "reasonably comfortable". The studies were partly funded and designed by their respective manufacturers, with varying levels of corporate input to university investigators. In both cases, researchers were free to publish results as they considered appropriate. Scientists don't know exactly how the cooling caps work. One theory is that cooling narrows the blood vessels in the scalp, slowing down circulation and thereby reducing the amount of toxins the hair follicles are exposed to. Or it may be that the cold slows down the growth of the hair follicles, making them less sensitive to damage from chemotherapy, which targets rapidly dividing cells. Dr. Len Lichtenfeld, deputy chief physician of the American Cancer Society, says that "by slowing down these cells whatever mechanism it may be — either starve their blood flow or slow them down bluntly — the net effect is beneficial, causing the hair not to fall out." While cooling the scalp may seem to carry few risks, Lichtenfeld says there is a theoretical risk of inhibiting the effect of chemotherapy in the scalp may allow metastases to take hold there. "These techniques are relatively new," he says, and "breast cancer is a disease that can take a long time before it comes back and if you are to be 100 percent safe you need a long time to answer the question." So far, cancer relapse in the scalp has not been seen in US studies, but authors of both JAMA newspapers say longer follow-up is needed to be sure this is not a risk. TUESDAY, February 14, 2017 -- Scalp fridges can help breast cancer patients save their hair from ravages of chemotherapy, a couple of new studies suggest. More than half of the women with a cooling cap retained their hair during chemotherapy in the world's first randomized clinical trial of the devices, said lead researcher Dr. Julie Nangia. She is an assistant professor and breast cancer expert at Baylor College of Medicine in Houston. "The protest was stopped early because the device was so effective in the group receiving the device," said Nangia. "In our study, half of the women who used the scalp cooling device kept their hair, and in the control group there was zero percent hair retention. Anyone who didn't have the device lost their hair." A second study also showed that the cooling caps could reduce hair loss, with two thirds of patients losing half or less of their hair during chemotherapy, researchers reported. The studies were published Tuesday in the Journal of the American Medical Association. Both received funding from the manufacturers of the chillers used in each study, Paxman Coolers of England and Dignitana of Sweden respectively. Scalp refrigerators can help save lives by making chemotherapy more acceptable to breast cancer patients, Nangia said. About 50 percent of patients consider hair loss to be the most traumatic aspect of chemotherapy, and about 8 percent report that they would reduce chemotherapy due to this concern, an accompanying magazine editorial stated. "Every woman cries when I say they're going to lose their hair. There is a very emotional aspect to it," Nangia said. "When you lose your hair, it's part of your body image and your sexuality," she continued. "You also lose your anonymity and integrity. Everyone knows you're sick. You can't just go out and be a normal person." The hard drugs used in chemotherapy make the hair follicles weak and break. They also damage hair growth cells in follicles, which can stop the hair cycle completely or cause new hair to be easily shed. Scalp fridges seem to limit this damage by tightening the blood vessels of the scalp, reducing the amount of chemotherapy delivered to the hair follicles, explained Nangia. The cooling cap can also reduce the biochemical damage caused by the follicles by whatever the chemo gets through. Patients put on a tight cooling cap for half an hour before chemotherapy and leave it for 90 minutes to 120 minutes afterwards, according to the two studies. "The key is to have a tight fit, because if you have any gaps you will lose hair where there is no good contact," Nangia said. The Nangia clinical trial involved 182 breast cancer patients. Two thirds were randomly chosen to get scalp cooling, and the rest received chemotherapy without a cooling cap. However, the study was stopped after data came in for the first 142 patients and it was clear that cooling had a significant effect to slow down or stop hair loss, said Nangia. The second study, conducted at five medical centers in the United States and led by Dr. Hope Rugo of the University of California, San Francisco, included 101 breast cancer patients with a refrigerated cap and 16 patients in a control group. Again, all patients without the cap lost their hair, while hair loss was limited or stopped in those using the scalp cooling cap. The risk of hair loss varied greatly in both studies, depending on which medical center provided scalp cooling therapy and what chemo-medicines were used in the treatment, said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society. He wasn't involved in the research. The amount of experience a center had with the devices seemed to improve their ability to preserve the hair, and the relative hardness of the patient's chemotherapy also seemed to play a role, Lichtenfeld explained. "These devices prevent hair loss in some women, but it is highly operator-dependent and chemotherapy-dependent," Lichtenfeld said. Scalp chillers cost between $1,500 and $3,000 per patient in the United States, and are not replaced by health insurance, noted Nangia's study. It is not counting the time and cost of applying the device during chemo, Lichtenfeld added. Neither study found any short-term side effects caused by the cooling caps. However, there are concerns that cancer may reappear in a woman's scalp year after treatment, Lichtenfeld and Dr Richard Bleicher, breast clinical line leader with Fox Chase Cancer Center in Philadelphia said. Bleicher, also an associate professor of surgical oncology at Fox Chase, said that "there has been some concern that if minor chemotherapy circulates to the scalp, breast cancer metastases could have a greater probability of occurring there." Nangia acknowledged concerns about limiting the flow of chemo to the scalp could protect cancer cells hiding there. Both research groups plan to follow patients for at least five years to see if there is an increased risk of recurrence of cancer. Nangia added that previous European studies have found no effect on long-term cancer survival. For more on scalp cooling, visit the American Cancer Society. Copyright © 2017 HealthDay. All rights reserved. <unk>
– Kylmössor är enormt populära bland europeiska cellgiftspatienter och har gjort inbrytningar i USA, men två studier publicerade tisdag i Journal of the American Medical Association erbjuder några av de första kliniska bevisen på deras effektivitet. I den ena studien förlorade cirka två tredjedelar av bröstcancerpatienterna mindre än hälften av sitt hår; i den andra studien förlorade ungefär hälften av bröstcancerpatienterna mindre än hälften av sitt hår. New York Times rapporterar att 5% av patienterna behöll allt hår. Skillnaderna i effektivitet mellan studierna kan ha att göra med att kyllocken används, de medicinska centra som tillämpar locken, och de kemoläkemedel som är inblandade, enligt HealthDay News. Studierna finansierades av två olika företag som tillverkar kyllock. Kyllock fästs på patienternas huvuden före, under och efter cellgifter; en maskin cyklar kylvätska genom locken. Medan forskare är inte exakt säker på hur mössorna förhindrar håravfall, NPR rapporterar, en teori är att de begränsar blodkärlen i hårbotten, vilket minskar mängden cellgifter som når hårsäckarna. Ungefär hälften av bröstcancerpatienterna säger att håravfall är den mest skrämmande delen av cellgifterna, och 8% säger att de skulle tacka nej till cellgifter för att behålla håret. En av dem som överlevde bröstcancer och använde en kylmössa säger att den har psykologiska fördelar. Hon berättar för Times att förlora sitt hår får folk att tro att de är sjukare än de faktiskt är. (En dos magiska svampar hade stor effekt på cancerpatienter.)
“Cold caps are hugely popular among European chemo patients and have made inroads in the United States, but two studies published Tuesday in the Journal of the American Medical Association offer some of the first clinical evidence of their effectiveness. In one study, about two thirds of breast cancer patients lost less than half of their hair; in the other study, about half of breast cancer patients lost less than half of their hair. The New York Times reports that 5% of patients kept all their hair. The differences in effectiveness between the studies may have to do with the use of the cooling caps, the medical centers applying the caps, and the chemo-medicines involved, according to HealthDay News. The studies were financed by two different companies producing refrigeration caps. Cold lids are attached to the patients' heads before, during and after chemotherapy; a machine cycles coolant through the lids. While scientists are not exactly sure how the caps prevent hair loss, NPR reports, a theory is that they limit the blood vessels of the scalp, reducing the amount of chemotherapy that reaches the hair follicles. Approximately half of breast cancer patients say that hair loss is the most frightening part of the chemotherapy, and 8% say they would turn down chemotherapy to keep their hair. One of those who survived breast cancer and used a cooling cap says it has psychological benefits. She tells the Times to lose their hair makes people think they're sicker than they actually are. (A dose of magic mushrooms had a major effect on cancer patients.)