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ACTIVE NOT RECRUITING
NCT07201389
NA

CARE (Chemotherapy Alopecia REduction)

Sponsor: George Washington University

View on ClinicalTrials.gov

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

Interventions

DEVICE

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