CARE (Chemotherapy Alopecia REduction)

NCT07201389 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CARE (Scalp Cooling Protocol)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Success in hair preservation after at least four cycles of chemotherapy

  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.

  From enrollment to the end of study (2 years)

Secondary Outcomes (3)

• To estimate participant reported comfort of using Digniticap

  From enrollment to the end of study (2 years)

• Evaluate quality of life (QOL) during study treatment phase- HADS

  From enrollment to the end of study (2 years)

• Evaluate quality of life (QOL) during study treatment phase- BIS

  From enrollment to the end of study (2 years)

Study Arms (1)

Scalp Cooling Arm

EXPERIMENTAL

DigniCap Scalp Cooling will be applied to all participants undergoing chemotherapy

Device: Scalp Cooling by DigniCap

Interventions

Scalp Cooling by DigniCap DEVICE

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.

Scalp Cooling Arm

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Black women, black female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington-Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (3)

• Dilawari A, Gallagher C, Alintah P, Chitalia A, Tiwari S, Paxman R, Adams-Campbell L, Dash C. Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? Oncologist. 2021 Apr;26(4):292-e548. doi: 10.1002/onco.13690. Epub 2021 Feb 17.

  PMID: 33512741 BACKGROUND

• Benjamin B, Ziginskas D, Harman J, Meakin T. Pulsed electrostatic fields (ETG) to reduce hair loss in women undergoing chemotherapy for breast carcinoma: a pilot study. Psychooncology. 2002 May-Jun;11(3):244-8. doi: 10.1002/pon.593.

  PMID: 12112485 BACKGROUND

• Pozo-Kaderman C, Kaderman RA, Toonkel R. The psychosocial aspects of breast cancer. Nurse Pract Forum. 1999 Sep;10(3):165-74.

  PMID: 10614362 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Director, Division of Hematology Oncology

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 1, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)