CARE (Chemotherapy Alopecia REduction)

NAActive, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 24, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Breast CancerBreast - FemaleBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage IIIChemotherapy Induced Alopecia
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.

Trial Locations (1)

20037

George Washington-Medical Faculty Associates, Washington D.C.

All Listed Sponsors
lead

George Washington University

OTHER