MedStar Washington Hospital Center, Washington Cancer Institute, Lombardi Comprehensive Cancer Center, Washington, DC, USA.
MedStar Health Research Institute, Washington Cancer Institute, Washington, DC, USA.
Oncologist. 2021 Apr;26(4):292-e548. doi: 10.1002/onco.13690. Epub 2021 Feb 17.
Despite U.S. Food and Drug Administration approval to reduce alopecia, data on efficacy of scalp cooling in Black patients with cancer are limited by lack of minority representation in prior clinical trials. Scalp cooling devices may have less efficacy in Black patients; additional studies are required to explore the possible causes for this, including hair texture and cap design.
The Paxman scalp cooling (SC) device is U.S. Food and Drug Administration (FDA)-approved for prevention of chemotherapy-induced alopecia. Studies report 50%-80% success rates and high patient satisfaction, yet there have been no studies of SC in Black patients. We conducted a phase II feasibility study of Paxman SC with a planned enrollment of 30 Black patients receiving chemotherapy for stage I-III breast cancer.
Black patients who planned to receive at least four cycles of chemotherapy with non-anthracycline (NAC) or anthracycline (AC) regimens were eligible. Alopecia was assessed by trained oncology providers using the modified Dean scale (MDS) prior to each chemotherapy session. Distress related to alopecia was measured by the Chemotherapy Alopecia Distress Scale (CADS).
Fifteen patients enrolled in the intervention before the study was closed early because of lack of efficacy. Median MDS and CADS increased after SC, suggesting increased hair loss (p < .001) and alopecia distress (p = .04). Only one participant was successful in preventing significant hair loss; the majority stopped SC before chemotherapy completion because of grade 3 alopecia (>50% hair loss).
SC may not be efficacious in preventing alopecia in Black women. Differences in hair thickness, hair volume, and limitations of cooling cap design are possible contributing factors.
尽管美国食品和药物管理局 (FDA) 批准减少脱发,但由于先前临床试验中缺乏少数族裔代表,头皮冷却在癌症黑人患者中的疗效数据有限。头皮冷却装置在黑人患者中的效果可能较差;需要进一步研究探索造成这种情况的可能原因,包括头发质地和帽子设计。
Paxman 头皮冷却 (SC) 装置已获得美国食品和药物管理局 (FDA) 批准,可预防化疗引起的脱发。研究报告成功率为 50%-80%,患者满意度高,但尚未有 SC 在黑人患者中的研究。我们对 Paxman SC 进行了 II 期可行性研究,计划招募 30 名接受 I-III 期乳腺癌化疗的黑人患者。
计划接受至少四个周期非蒽环类 (NAC) 或蒽环类 (AC) 方案化疗的黑人患者符合条件。在每次化疗前,由经过培训的肿瘤学提供者使用改良 Dean 量表 (MDS) 评估脱发情况。脱发相关的困扰通过化疗脱发困扰量表 (CADS) 进行测量。
在研究因疗效不佳而提前关闭之前,有 15 名患者入组了干预组。使用 SC 后 MDS 和 CADS 中位数增加,提示脱发增加(p <.001)和脱发困扰增加(p =.04)。只有一名参与者成功预防了明显的脱发;由于 3 级脱发(>50%的头发脱落),大多数人在化疗完成前停止使用 SC。
SC 可能无法有效预防黑人女性的脱发。头发厚度、头发体积和冷却帽设计的局限性可能是造成这种差异的原因。