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CARE (Chemotherapy Alopecia REduction)
Sponsor: George Washington University
Summary
The goal of this research study is to determine if the DigniCap Scalp Cooling System can help prevent chemotherapy-induced hair loss in Black patients.
Official title: A Study to Investigate DigniCap Scalp Cooling on Black Patients for Prevention of Chemotherapy-induced Alopecia.
Key Details
Gender
FEMALE
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-09-24
Completion Date
2027-09
Last Updated
2025-10-01
Healthy Volunteers
No
Conditions
Interventions
Scalp Cooling by DigniCap
Scalp cooling with the DigniCap Delta will occur with each chemotherapy dose. The cooling wrap is primed, fitted, and checked for proper contact before a standardized pre-cool phase of 20-30 minutes. Cooling continues during chemotherapy, followed by a post-cool phase of 90-180 minutes based on regimen. The system circulates temperature-controlled coolant through channels in the wrap, with sensors monitoring flow and scalp temperature; a safety sensor ensures scalp temperature never falls below 32°F (0°C). Alerts notify staff of low flow or temperature issues. After cooling, the cap is loosened for 5 minutes to warm before removal, and subjects are given 5 minutes to acclimate before standing.
Locations (1)
George Washington-Medical Faculty Associates
Washington D.C., District of Columbia, United States