头皮冷却预防乳腺癌化疗持续脱发

头皮冷却预防乳腺癌化疗持续脱发

化疗所致脱发是乳腺癌化疗最常见和最严重的不良事件之一。虽然化疗所致脱发通常被认为是暂时的，但是部分患者即使完成化疗数年仍然出现完全或部分头发再生缺失，该现象称为化疗所致持续或永久脱发。2012年法国蒙彼利埃第一大学圣埃洛伊医院前瞻研究结果表明，乳腺癌患者化疗后3年头发再生不全比例高达42.3%，该队列化疗后6个月头发平均密度恢复到化疗前水平，但是头发平均直径并未恢复，这表明化疗可破坏毛囊细胞，并对毛干质量产生长期影响。虽然用于预防或治疗化疗所致脱发的药物和物理方法已经被研发，但是大多数治疗或预防化疗所致持续脱发的方法效果有限。不少研究已证实头皮冷却对于预防化疗期间脱发的效果，但是对化疗所致持续脱发效果的证据极少。既往头皮冷却研究仅对化疗完成后1～2个月（最多12周）头发保存比例进行评定，并未长期随访头发质量恢复到化疗前的情况。

2024年6月6日，美国临床肿瘤学会官方期刊《临床肿瘤学杂志》在线发表韩国成均馆大学医学院三星首尔医院、美国霍普金斯大学医学院和布隆博格公共卫生学院的PAXMAN研究报告，首次对头皮冷却减少乳腺癌患者化疗后6个月化疗所致持续脱发的效果进行随机对照。

PAXMAN (NCT04678544): Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients (Official Title: A Randomized Controlled Trial to Evaluate Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-induced Alopecia Among Breast Cancer Patients)

该单中心非盲随机对照研究于2020年12月至2021年8月从韩国成均馆大学医学院三星首尔医院入组新诊断I～III期乳腺癌计划进行术前新辅助化疗或者术后辅助化疗患者170例，按2∶1随机分为两组，其中113例给予头皮冷却，其余57例给予常规治疗。

主要结局为化疗后6个月化疗所致持续脱发。采用手持式数码显微镜测量头发直径和密度，根据化疗所致脱发痛苦量表对化疗所致脱发相关痛苦进行评分，分数越高，痛苦越大。

结果，6个月时，头皮冷却组与对照组相比：

• 化疗所致持续脱发比例：13.5%比52.0%
• 头发直径与化疗前相比：+1.5µm比-7.5µm
• 头发密度与化疗前相比：5.6/cm²比8.9/cm²
• 化疗所致脱发痛苦评分：3.9比7.0

因此，该研究结果表明，对于早期乳腺癌化疗患者，头皮冷却组与对照组相比，化疗后6个月时，化疗所致持续脱发比例大幅降低，主要由于头发直径增粗，头发密度并未增加。头皮冷却有助促进头发粗壮，并且显著减少化疗所致脱发相关心理困扰。不过，仍然需要进一步研究观察头皮冷却长期获益。

相关链接

• 情人节当天《美国医学会杂志》同时发表关于乳腺癌女性化疗脱发的两篇研究和两篇评论……
• 英国头皮冷却装置对乳腺癌女性化疗脱发的影响：随机研究
• 瑞典头皮冷却装置与乳腺癌化疗后脱发的相关性：队列研究
• 乳腺癌化疗后脱发与头皮冷却预防
• 头皮冷却对乳腺癌化疗脱发的作用
• 预防早期乳腺癌患者化疗所致脱发

J Clin Oncol. 2024 Jun 6. IF: 45.3

Scalp Cooling in Preventing Persistent Chemotherapy-Induced Alopecia: A Randomized Controlled Trial.

Kang D, Cho J, Zhao D, Kim J, Kim N, Kim H, Kim S, Kim JY, Park YH, Im YH, Guallar E, Ahn JS.

Samsung Medical Center, Sungkyunkwan University School of Medicine, Sungkyunkwan University, Seoul, Korea; Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medical Institutions, Baltimore, MD.

PURPOSE: Current studies of the efficacy of scalp cooling are limited by short-term duration. Therefore, we conducted a randomized controlled trial to evaluate the efficacy of scalp cooling in reducing persistent chemotherapy-induced alopecia (PCIA) 6 months after chemotherapy.

METHODS: We conducted an open-label randomized controlled trial comparing scalp cooling versus control in newly diagnosed patients with breast cancer stages I-III scheduled to receive neoadjuvant or adjuvant chemotherapy with curative intent between December 2020 and August 2021. Patients were randomly assigned (2:1 ratio) to scalp cooling or usual clinical practice. The primary outcome was PCIA 6 months after chemotherapy. Hair thickness and density were measured using Folliscope 5.0. CIA-related distress was assessed using the CIA distress scale (CADS), with a higher score reflecting higher stress.

RESULTS: The proportion of patients with PCIA at 6 months was 13.5% (12/89) in the scalp-cooling group and 52.0% (26/50) in the control group. The average difference in the change in hair thickness from baseline between the scalp-cooling and control groups was 9.0 μm in favor of the intervention group. The average difference in the change in hair density between intervention and control at the end of the study was -3.3 hairs/cm2. At 6 months after chemotherapy, the average difference in the change in CADS score between the intervention and control groups was -3.2 points, reflecting reduced CIA-related stress in the intervention group.

CONCLUSION: Scalp cooling reduced the incidence of PCIA, primarily by increasing hair thickness compared with control. Scalp cooling is helpful in promoting qualitative hair regrowth. Yet, further research is necessary to observe longer-term benefits of scalp cooling.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04678544

PMID: 38843479

DOI: 10.1200/JCO.23.02374