Asma Dilawari1, Christopher Gallagher1, Princess Alintah2, Ami Chitalia1, Shruti Tiwari1, Richard Paxman3, Lucile Adams-Campbell4, Chiranjeev Dash4
1MedStar Washington Hospital Center, Washington Cancer Institute, Lombardi Comprehensive Cancer Center, Washington, DC, USA.
2MedStar Health Research Institute, Washington Cancer Institute, Washington, DC, USA.
3Paxman Scalp Cooling, Huddersfield, United Kingdom.
4Georgetown University, Office of Minority Health and Cancer Prevention and Control, Washington, DC, USA.
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.
Trial registration: ClinicalTrials.gov NCT04626895.
Breast cancer; Chemotherapy-induced alopecia; Paxman scalp cooling device.
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