CARE (Chemotherapy Alopecia REduction)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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 objective of this study is to provide a preliminary assessment of the efficacy of the DigniCap Scalp Cooling in Black patients as prevention for chemotherapy induced alopecia.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Diagnosed with early stage breast cancer (stage I-III)
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Self-identify as Black
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Planned therapy with taxane and/or anthracycline-based chemotherapy (at least 4 cycles must be planned)
-≥ 21 years of age
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Able to give informed consent
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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