Trials / Active Not Recruiting
Active Not RecruitingNCT07201389
CARE (Chemotherapy Alopecia REduction)
A Study to Investigate DigniCap Scalp Cooling on Black Patients for Prevention of Chemotherapy-induced Alopecia.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- George Washington University · Academic / Other
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Breast Cancer
- Breast - Female
- Breast Cancer Stage I
- Breast Cancer Stage II
- Breast Cancer Stage III
- Chemotherapy Induced Alopecia
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-09-24
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2025-10-01
- Last updated
- 2025-10-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07201389. Inclusion in this directory is not an endorsement.