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

A Pilot Study of Low-Level Red-Light Therapy Combined With Topical Minoxidil Compared With Topical Minoxidil Alone in Breast Cancer Patients With Chemotherapy-Induced Alopecia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To determine the change in the quality-of-life Chemotherapy Alopecia Distress Scale (CADS) questionnaire score in patients with chemotherapy-induced alopecia following treatment with LLLT and topical minoxidil versus topical minoxidil alone."
  • "ARM I: Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity."
  • "ARM II: 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests minoxidil applied to the skin, with or without low-level red-light therapy, for hair loss caused by chemotherapy. It compares how safe the treatments are and how well they help hair grow back. It is for Ohio State University patients older than 18 who have breast cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be an Ohio State University patient older than 18.
  • Have stage I–IV (1–4) breast cancer.
  • Have received chemotherapy that included an anthracycline or taxane drug.
  • Have lost at least half of your scalp hair by your last chemotherapy infusion.
  • You may join if you used scalp cooling.

Who can't join

  • Are pregnant or breastfeeding.
  • Have a history of hair loss caused by scarring, or alopecia areata, which causes patchy hair loss.
  • Have a known sensitivity to minoxidil.
  • Are currently receiving an antibody-drug conjugate (a drug linked to an antibody) or immunotherapy (treatment that uses the immune system to fight cancer).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * NOTE: There is no exclusion criteria for utilization of scalp cooling

Study sites (1)

OH