Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients

NCT07594678 | Not Yet Recruiting Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: OSU-24393NCI-2026-02583
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Dean scale score

  The Dean scale measures hair loss along a 4-grade scale. Grade 1 = \<25% hair loss. Grade 2= 25-50% hair loss. Grade 3=50-75% hair loss. Grade 4 = \>75% hair loss. Success will be defined as Dean scale score of 1 or 0. This will be based on clinical photographs taken at the initial and 6-month visits and scored by two board-certified dermatologists. Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups, including the proportion of patients with a Dean score of 1 or 0 at 6 months.

  After 6 months of intervention

Secondary Outcomes (7)

• Change in Dean scale score

  From baseline to 2, 4, and 12 months

• Change in trichoscopic hair density

  From baseline to 2, 4, 6, and 12 months

• Change in Chemotherapy Alopecia Distress Scale (CADS)

  From baseline to 2, 4, 6, and 12 months

• Change in patient reported outcomes (hair loss survey)

  From baseline to 2, 4, 6, and 12 months

• Change in patient reported outcomes (feelings survey)

  From baseline to 2, 4, 6, and 12 months

Study Arms (2)

Arm I (minoxidil)

ACTIVE COMPARATOR

Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.

Other: Electronic Health Record Review; Drug: Minoxidil; Other: Survey Administration

Arm II (minoxidil, LLLT)

EXPERIMENTAL

Patients receive minoxidil topically to the scalp daily and undergo low-level red-light therapy with the Revian RED LED-light cap over 10 minutes daily for 6 months in the absence of unacceptable toxicity.

Other: Electronic Health Record Review; Drug: Minoxidil; Device: Revian RED LED-light cap; Other: Survey Administration

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Arm I (minoxidil); Arm II (minoxidil, LLLT)

Minoxidil DRUG

Given topically

Also known as: Alostil, Loniten, Rogaine, U 10858

Arm I (minoxidil); Arm II (minoxidil, LLLT)

Revian RED LED-light cap DEVICE

Undergo low-level red-light therapy with Revian RED LED-light cap

Arm II (minoxidil, LLLT)

Survey Administration OTHER

Ancillary studies

Arm I (minoxidil); Arm II (minoxidil, LLLT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be Ohio State University patients \> 18 years old
• Patients will have a diagnosis of breast cancer, stages I-IV
• Patients will have been treated with a chemotherapy regimen containing either an anthracycline or taxane
• Patients will have a loss of at least 50% of the hair on the scalp by the final chemotherapy infusion
• Patients will NOT be pregnant or nursing women
• Patients will NOT have a history of scarring/cicatricial alopecia or alopecia areata
• Patients will NOT have a known sensitivity to minoxidil
• Patients will NOT have ongoing treatment with an antibody-drug conjugate or immunotherapy

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Minoxidil

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Brittany L Dulmage, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Clinical treatment response will be scored by a blinded investigator.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): July 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

US (1)