Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients
NCT07594678 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-05-19
Summary
This phase II trial compares the safety and effectiveness of topical minoxidil alone to topical minoxidil in combination with low-level red-light therapy for improving chemotherapy-induced hair loss or thinning (alopecia). Minoxidil has been approved by the Food and Drug Administration as a treatment for hair loss. It increases blood flow in the skin and may have a direct stimulatory effect on hair follicle cells, forcing them from their resting phase into their active growth phase. Low-level light therapy is regarded as a safe and medically accepted treatment for a variety of skin conditions, including acne, scars, and psoriasis. Red light wavelengths are readily absorbed into the skin and do not contain harmful ultraviolet light. When absorbed into the skin, these wavelengths stimulate fibroblasts, which are connective tissue cells that make and secrete collagen proteins. Low-level red-light therapy may improve hair loss by stimulating hair follicles. Combining minoxidil with low-level red-light therapy may be safe and more effective at improving chemotherapy-induced alopecia than minoxidil alone.
Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Chemotherapy-Induced Alopecia
Interventions
- OTHER
-
Electronic Health Record Review
Ancillary studies
- DRUG
-
Given topically
- DEVICE
-
Revian RED LED-light cap
Undergo low-level red-light therapy with Revian RED LED-light cap
- OTHER
-
Survey Administration
Ancillary studies
Sponsors & Collaborators
-
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Brittany L Dulmage, MD · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-02
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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