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CARE (Chemotherapy Alopecia REduction)

NCT07201389 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-01

No results posted yet for this study

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

Interventions

DEVICE

Scalp Cooling by DigniCap

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.

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-24
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201389 on ClinicalTrials.gov