CARE (Chemotherapy Alopecia REduction)

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Breast - Female; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Chemotherapy Induced Alopecia

• Registration Number: NCT07201389
• Lead Sponsor: George Washington University

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 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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-24
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Success in hair preservation after at least four cycles of chemotherapy	From enrollment to the end of study (2 years)	Success is defined as CTCAE v5.0 alopecia grade 0 (no hair loss) or grade 1 (\<50% hair loss not requiring a wig). Failure is defined as CTCAE v5.0 grade 2 (≥50% hair loss, requiring use of a wig) or higher.

Secondary Outcome Measures

Name	Time	Method
To estimate participant reported comfort of using Digniticap	From enrollment to the end of study (2 years)	Participants will be asked if they find the procedure acceptable or unacceptable based on comfort scale used in Massey study (2004). The scale range: Question for participant: How comfortable were you in general throughout the scalp cooling period?; Scale: 1. Very Comfortable; 2. Reasonably Comfortable; 3. Comfortable; 4. Uncomfortable; 5. Very Uncomfortable
Evaluate quality of life (QOL) during study treatment phase- HADS	From enrollment to the end of study (2 years)	QOL will be assessed by the HADS (anxiety summary and depression summary). It will be administered at baseline, after 4 cycles (except if someone is on weekly regimen, then the assessments will be done every 2 weeks x 4 times) and then after completion of chemotherapy (if the subject is receiving more than 4 cycles).; 1.The HADS will be used to assess anxiety and depression. It includes 7 questions to assess anxiety and 7 to assess depression. The summary scores (sum of the 7 question items) for anxiety and depression range from 0 to 21: scores of 0 to 7 are considered normal, 8 to 10 are considered borderline abnormal (borderline case), and 11 to 21 are considered abnormal (case).
Evaluate quality of life (QOL) during study treatment phase- BIS	From enrollment to the end of study (2 years)	QOL will be assessed by the BIS (body image scale appendix included protocol). It will be administered at baseline, after 4 cycles (except if someone is on weekly regimen, then the assessments will be done every 2 weeks x 4 times) and then after completion of chemotherapy (if the subject is receiving more than 4 cycles).; 1\. The BIS summary score will be the sum of the first 9 (of 10) items in the BIS. The summary score ranges from 0 to 27; a score of 0 indicates no symptoms or distress, and a higher score indicates increasing symptoms or distress.

Trial Locations

Locations (1)

George Washington-Medical Faculty Associates; 🇺🇸 Washington D.C., District of Columbia, United States