Status:
ACTIVE_NOT_RECRUITING
CARE (Chemotherapy Alopecia REduction)
Lead Sponsor:
George Washington University
Conditions:
Breast Cancer
Breast - Female
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief 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.
Detailed Description
The purpose of this study is to assess whether the DigniCap Scalp Cooling System can help prevent chemotherapy-induced hair loss in Black patients undergoing treatment for breast cancer. The primary o...
Eligibility Criteria
Inclusion
- Diagnosed with early stage breast cancer (stage I-III)
- Self-identify as Black
- Planned therapy with taxane and/or anthracycline-based chemotherapy (at least 4 cycles must be planned)
- ≥ 21 years of age
- Able to give informed consent
Exclusion
- Female pattern hair loss or hair loss disorder
- Scalp folliculitis
- Scalp psoriasis Scalp seborrheic dermatitis
- Inflammatory scalp conditions such as lichen planopillaris or alopecia areata
- Subjects wearing wigs or subjects who shave their hair prior to chemotherapy
- Unable to provide consent or make allotted clinical visits
- Subjects with cold agglutinin disease or cold urticaria
- Unwilling to remove hair extensions during treatment phase which can interfere with study assessments
- History or whole brain irradiation
- History of prior systemic chemotherapy
Key Trial Info
Start Date :
September 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07201389
Start Date
September 24 2025
End Date
September 1 2027
Last Update
October 1 2025
Active Locations (1)
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1
George Washington-Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037