CARE (Chemotherapy Alopecia REduction)

A Study to Investigate DigniCap Scalp Cooling on Black Patients for Prevention of Chemotherapy-induced Alopecia.

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.

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.

Inclusion Criteria:

• 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 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