No effect of scalp cooling on survival among women with breast cancer

IMPORTANCE Chemotherapy-induced alopecia is a common and distressing adverse effect. In previous studies of scalp cooling to prevent chemotherapy-induced alopecia, conclusions have been limited.OBJECTIVES To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life. DESIGN, SETTING, AND PARTICIPANTSA prospective cohort study conducted at 5 US medical centers of women with stage I or II breast cancer receiving adjuvant or neoadjuvant chemotherapy regimens excluding sequential or combination anthracycline and taxane (106 patients in the scalp cooling group and 16 in the control group; 14 matched by both age and chemotherapy regimen). The study was conducted between August 2013 and October 2014 with ongoing annual follow-up for 5 years.EXPOSURES Use of a scalp cooling system. Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward.MAIN OUTCOMES AND MEASURES Self-estimated hair loss using the Dean scale was assessed 4 weeks after the last dose of chemotherapy by unblinded patient review of 5 photographs. A Dean scale score of 0 to 2 (Յ50% hair loss) was defined as treatment success. A positive association between scalp cooling and reduced risk of hair loss would be demonstrated if 50% or more of patients in the scalp cooling group achieved treatment success, with the lower bound of the 95% CI greater than 40% of the success proportion. Quality of life was assessed at baseline, at the start of the last chemotherapy cycle, and 1 month later. Median follow-up was 29.5 months. RESULTS Among the 122 patients in the study, the mean age was 53 years (range, 28-77 years); 77.0% were white, 9.0% were black, and 10.7% were Asian; and the mean duration of chemotherapy was 2.3 months (median, 2.1 months). No participants in the scalp cooling group received anthracyclines. Hair loss of 50% or less (Dean score of 0-2) was seen in 67 of 101 patients (66.3%; 95% CI, 56.2%-75.4%) evaluable for alopecia in the scalp cooling group vs 0 of 16 patients (0%) in the control group (P < .001). Three of 5 quality-of-life measures were significantly better 1 month after the end of chemotherapy in the scalp cooling group. Of patients who underwent scalp cooling, 27.3% (95% CI, 18.0%-36.6%) reported feeling less physically attractive compared with 56.3% (95% CI, 31.9%-80.6%) of patients in the control group (P = .02). Of the 106 patients in the scalp cooling group, 4 (3.8%) experienced the adverse event of mild headache and 3 (2.8%) discontinued scalp cooling due to feeling cold.CONCLUSIONS AND RELEVANCE Among women undergoing non-anthracycline-based adjuvant chemotherapy for early-stage breast cancer, the use of scalp cooling vs no scalp cooling was associated with less hair loss at 4 weeks after the last dose of chemotherapy. Further research is ne...

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“…13 Based on these and other data, the risk of scalp metastases after receipt of scalp cooling treatment appears to be very small. 10–13 …”

Section: Discussionmentioning

confidence: 88%

“…Recent studies showed no association between scalp cooling and scalp metastases or decreased survival among patients with breast cancer, 10–13 reducing these concerns.…”

mentioning

confidence: 99%

Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer

Rugo

Klein

Melin

et al. 2017

JAMA

141

103

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“…However, MDs who already offer SC perceived it as a service for their patients and were satisfied with the results. Doubts about effectiveness[2122] and safety[2930] of SC are no longer valid reasons for not introducing the treatment in hospitals.…”

Section: Resultsmentioning

confidence: 99%

Familiarity, opinions, experiences and knowledge about scalp cooling: a Dutch survey among breast cancer patients and oncological professionals

Peerbooms

Hurk

Breed

2015

Asia-Pacific Journal of Oncology Nursing

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Objective:Scalp cooling (SC) is applied to reduce chemotherapy-induced alopecia (CIA). The aim of this study was to investigate patients’ familiarity and opinions and oncological professionals’ attitude and knowledge about SC in the Netherlands.Methods:Ex breast cancer patients, nurses and medical oncologists (MDs) from SC and non-SC hospitals filled out questionnaires.Results:The majority of MDs and nurses were satisfied with the results of SC, as were SC patients. Over 33% of MDs and nurses perceived their knowledge level insufficient to inform patients about effectiveness, which was over 43% for information about safety. MDs main reason to not apply SC was doubt about effectiveness and safety. Nurses generally offered SC to a minority of eligible patients. Patients were frequently unfamiliar with SC before diagnosis. Seventy percent of SC patients with insufficient results (20/52) reported to mind it very much. With expected success rates of 35% and 50%, respectively, 36% and 54% of patients would use SC again.Conclusion:Room for improvement has been shown for both patients’ familiarity and oncological professionals’ knowledge about SC. Sharing knowledge about results, safety and patients’ experiences will improve patient counseling and SC availability. The results of this survey led to the development of a national standard on CIA and SC.

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“…Six patients (1.1%) in the scalp cooling group of 553 and one patient in the control group of 87 (1.2%) developed scalp metastasis. The rate of scalp metastasis in the scalp cooling group and the control group was not statistically different, as was the overall rate of survival ( P = 0.40) . Grevelman and Breed reviewed 56 studies on CIA and reported scalp metastasis in only nine out of approximately 2500 patients .…”

Section: Discussionmentioning

confidence: 94%

Scalp hypothermia as a preventative measure for chemotherapy‐induced alopecia: a review of controlled clinical trials

Shah

Wikramanayake

DelCanto

et al. 2017

Acad Dermatol Venereol

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Chemotherapy-induced alopecia (CIA) is a temporary, yet psychologically devastating form of hair loss that affects 65% of patients receiving cancer chemotherapy. In the 1970s, scalp hypothermia was introduced as a preventative measure against the development of CIA. Numerous studies provide evidence for the effectiveness of scalp cooling to prevent CIA, although results varied because of differences in chemotherapy regimen, cooling technique, mode of administration and patient factors. However, many of the existing studies are uncontrolled or consist of small sample sizes, and data from randomized, randomized studies are limited. To date, no clear guidelines have been established for optimum scalp cooling use as a treatment modality and its efficacy remain unknown. Nonetheless, scalp cooling remains the most widely utilized method for the prevention of CIA, and in December 2015, the United States Food and Drug Administration (FDA) cleared the DigniCap Scalp Cooling System (Dignitana AB, Sweden) for marketing and the Orbis from Paxman Coolers Ltd. received clearance in 2017. This literature review is one of the first to provide up-to-date review and side-by-side comparisons of controlled and randomized clinical trials (CCTs and RCTs) evaluating scalp hypothermia for the prevention of CIA. Our analyses of CCTs and RCTs to date show that scalp hypothermia is effective in reducing the occurrence rate of CIA, by 2.7-fold in the CCTs and 3.9-fold in the RCTs. These results suggest that scalp hypothermia represents an effective preventative measure for CIA, and provide guidance for management of anticipated alopecia following chemotherapy and for future investigations.

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No effect of scalp cooling on survival among women with breast cancer

Cited by 29 publications

References 11 publications

Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer

Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer

Familiarity, opinions, experiences and knowledge about scalp cooling: a Dutch survey among breast cancer patients and oncological professionals

Scalp hypothermia as a preventative measure for chemotherapy‐induced alopecia: a review of controlled clinical trials

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