Effect of a scalp cooling device on alopecia inwomen undergoing chemotherapy for breast cancer: The SCALP randomized clinical trial

Julie Nangia, Tao Wang, Cynthia Osborne, Polly Niravath, Kristen Otte, Steven Papish, Frankie Holmes, Jame Abraham, Mario Lacouture, Jay Courtright, Richard Paxman, Mari Rude, Susan Hilsenbeck, Kent Osborne, Mothaffar Rimawi

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Abstract

Importance Chemotherapymay 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 ofwomenwith breast cancer undergoing chemotherapy. Patientswere enrolled from December 9, 2013, to September 30, 2016. One interim analysiswas planned to allowthe study to stop early for efficacy.Data reported are from the interim analysis. This studywas conducted at 7 sites in the United States, and 182women with breast cancer requiring chemotherapywere 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 pointswere successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade0[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.

Original languageEnglish (US)
Pages (from-to)596-605
Number of pages10
JournalJAMA - Journal of the American Medical Association
Volume317
Issue number6
DOIs
StatePublished - Feb 14 2017

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Alopecia
Scalp
Randomized Controlled Trials
Breast Neoplasms
Drug Therapy
Equipment and Supplies
Hair
Anthracyclines
Clinical Trials Data Monitoring Committees
Quality of Life
Equipment Safety
Control Groups
Body Image
Terminology
Anxiety
Depression
Therapeutics
Research

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Nangia, Julie ; Wang, Tao ; Osborne, Cynthia ; Niravath, Polly ; Otte, Kristen ; Papish, Steven ; Holmes, Frankie ; Abraham, Jame ; Lacouture, Mario ; Courtright, Jay ; Paxman, Richard ; Rude, Mari ; Hilsenbeck, Susan ; Osborne, Kent ; Rimawi, Mothaffar. / Effect of a scalp cooling device on alopecia inwomen undergoing chemotherapy for breast cancer : The SCALP randomized clinical trial. In: JAMA - Journal of the American Medical Association. 2017 ; Vol. 317, No. 6. pp. 596-605.
@article{641ebf10df2b43c99f2bc9682630fb09,
title = "Effect of a scalp cooling device on alopecia inwomen undergoing chemotherapy for breast cancer: The SCALP randomized clinical trial",
abstract = "Importance Chemotherapymay 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 ofwomenwith breast cancer undergoing chemotherapy. Patientswere enrolled from December 9, 2013, to September 30, 2016. One interim analysiswas planned to allowthe study to stop early for efficacy.Data reported are from the interim analysis. This studywas conducted at 7 sites in the United States, and 182women with breast cancer requiring chemotherapywere 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 pointswere successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade0[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.",
author = "Julie Nangia and Tao Wang and Cynthia Osborne and Polly Niravath and Kristen Otte and Steven Papish and Frankie Holmes and Jame Abraham and Mario Lacouture and Jay Courtright and Richard Paxman and Mari Rude and Susan Hilsenbeck and Kent Osborne and Mothaffar Rimawi",
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Nangia, J, Wang, T, Osborne, C, Niravath, P, Otte, K, Papish, S, Holmes, F, Abraham, J, Lacouture, M, Courtright, J, Paxman, R, Rude, M, Hilsenbeck, S, Osborne, K & Rimawi, M 2017, 'Effect of a scalp cooling device on alopecia inwomen undergoing chemotherapy for breast cancer: The SCALP randomized clinical trial', JAMA - Journal of the American Medical Association, vol. 317, no. 6, pp. 596-605. https://doi.org/10.1001/jama.2016.20939

Effect of a scalp cooling device on alopecia inwomen undergoing chemotherapy for breast cancer : The SCALP randomized clinical trial. / Nangia, Julie; Wang, Tao; Osborne, Cynthia; Niravath, Polly; Otte, Kristen; Papish, Steven; Holmes, Frankie; Abraham, Jame; Lacouture, Mario; Courtright, Jay; Paxman, Richard; Rude, Mari; Hilsenbeck, Susan; Osborne, Kent; Rimawi, Mothaffar.

In: JAMA - Journal of the American Medical Association, Vol. 317, No. 6, 14.02.2017, p. 596-605.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effect of a scalp cooling device on alopecia inwomen undergoing chemotherapy for breast cancer

T2 - The SCALP randomized clinical trial

AU - Nangia, Julie

AU - Wang, Tao

AU - Osborne, Cynthia

AU - Niravath, Polly

AU - Otte, Kristen

AU - Papish, Steven

AU - Holmes, Frankie

AU - Abraham, Jame

AU - Lacouture, Mario

AU - Courtright, Jay

AU - Paxman, Richard

AU - Rude, Mari

AU - Hilsenbeck, Susan

AU - Osborne, Kent

AU - Rimawi, Mothaffar

PY - 2017/2/14

Y1 - 2017/2/14

N2 - Importance Chemotherapymay 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 ofwomenwith breast cancer undergoing chemotherapy. Patientswere enrolled from December 9, 2013, to September 30, 2016. One interim analysiswas planned to allowthe study to stop early for efficacy.Data reported are from the interim analysis. This studywas conducted at 7 sites in the United States, and 182women with breast cancer requiring chemotherapywere 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 pointswere successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade0[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.

AB - Importance Chemotherapymay 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 ofwomenwith breast cancer undergoing chemotherapy. Patientswere enrolled from December 9, 2013, to September 30, 2016. One interim analysiswas planned to allowthe study to stop early for efficacy.Data reported are from the interim analysis. This studywas conducted at 7 sites in the United States, and 182women with breast cancer requiring chemotherapywere 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 pointswere successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade0[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.

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