Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial.
💡 한 문장 핵심
유방암 항암화학요법을 받는 여성의 탈모에 대한 두피 냉각 장치의 효과: SCALP 무작위 임상시험.
5/5 보강
TL;DR
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.
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
142 participants were evaluable.
I · Intervention 중재 / 시술
anthracycline-based chemotherapy and 64% (n = 91) received taxane-based chemotherapy
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Further research is needed to assess longer-term efficacy and adverse effects. [TRIAL REGISTRATION] clinicaltrials.gov Identifier: NCT01986140.
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· 인용됨 46
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연도별 인용 (2017–2026) · 합계 223
OpenAlex 토픽 ·
Hair Growth and Disorders
Chemotherapy-related skin toxicity
Oral health in cancer treatment
🇰🇷 한글 요약 🌐 Abstract
【연구 목적】
유방암(breast cancer) 항암화학요법으로 유발되는 탈모(chemotherapy-induced alopecia)에 대해 두피 냉각장치(scalp cooling device)의 예방 효과와 안전성을 무작위배정 임상시험으로 평가하고자 하였다.
【방법】
미국 7개 기관에서 항암화학요법(탁산계 또는 안트라사이클린계)을 받는 유방암 여성 182명을 두피 냉각군(n=119)과 대조군(n=63)으로 무작위 배정한 다기관 RCT이다. 1차 평가지표는 항암 4주기 종료 시점에 CTCAE v4.0 기준 grade 0–1(50% 미만 탈모, 가발 불필요)에 해당하는 모발 보존 성공률 및 기기 안전성이었다.
【주요 결과】
중간 분석 시점에서 모발 보존 성공률은 냉각군 50.5%(48/95) vs 대조군 0%(0/47)로 약 50.5%p 차이를 보였고(P<.001), 우월성 기준을 충족해 조기 종료되었다. 삶의 질 지표(EORTC QLQ-C30, HADS, BIS)는 군간 유의차가 없었으며, 이상반응 54건은 모두 grade 1–2로 중대한 기기 관련 부작용은 없었다.
【임상적 시사점 (성형외과 의사 관점)】
항암 탈모 예방을 위한 두피 냉각요법은 절반 수준의 환자에서 가발 없이 견딜 만한 모발 보존을 제공하므로, 모발이식(hair transplantation)이나 미녹시딜 등 사후 치료에 앞서 항암 시작 전 단계의 예방적 옵션으로 환자에게 안내할 가치가 있다. 다만 본 연구는 4주기 시점의 단기 결과이므로, 장기 추적 후 잔존 탈모에 대한 후속 모발이식·SMP(scalp micropigmentation) 상담 시 본 시술 병력을 확인하고 잔여 모낭 상태를 평가하는 것이 권장된다.
[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.
[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.
- 표본수 (n) 119
- p-value P = .0061
【연구 목적】 유방암(breast cancer) 항암화학요법으로 유발되는 탈모(chemotherapy-induced alopecia)에 대해 두피 냉각장치(scalp cooling device)의 예방 효과와 안전성을 무작위배정 임상시험으로 평가하고자 하였다.
APA 7
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, C. K., & Rimawi, M. (2017). Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer: The scalp randomized clinical trial.. JAMA, 317(6), 596-605. https://doi.org/10.1001/jama.2016.20939
Vancouver
Nangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, et al. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017;317(6):596-605. doi:10.1001/jama.2016.20939
AMA 11
Nangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, et al. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017;317(6):596-605. doi:10.1001/jama.2016.20939
Chicago
Nangia, J., Wang, T., Osborne, C., Niravath, P., Otte, K., Papish, S., Holmes, F., Abraham, J., Lacouture, M., Courtright, J., and .... 2017. "Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial." JAMA 317 (6): 596-605. https://doi.org/10.1001/jama.2016.20939
MLA 9
Nangia, J., et al. "Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial." JAMA, vol. 317, no. 6, 2017, pp. 596-605. doi:10.1001/jama.2016.20939.
PMID
28196254 ↗
추출된 의학 개체 (NER)
전체 NER 표 보기
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 해부 | scalp
|
두피 | dict | 10 | |
| 해부 | scalp
|
두피 | dict | 10 | |
| 해부 | scalp
|
두피 | dict | 10 | |
| 해부 | breast
|
유방 | dict | 4 | |
| 해부 | breast
|
유방 | dict | 4 | |
| 해부 | breast
|
유방 | dict | 4 |
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
인용 관계
그래프 OA 노드: 8/8 (100%)
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