Minoxidil + Red-Light Therapy for Hair Loss in Breast Cancer

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to address hair loss from chemotherapy in breast cancer patients. One group will use minoxidil, a topical treatment that increases blood flow to hair follicles and promotes hair growth. The other group will use minoxidil combined with a red-light therapy cap, which may further stimulate hair growth by activating skin cells. Researchers aim to determine if the combination of these treatments is more effective than minoxidil alone. The trial seeks breast cancer patients who have lost at least half of their scalp hair after completing chemotherapy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in hair loss solutions.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not have ongoing treatment with an antibody-drug conjugate or immunotherapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that minoxidil is generally safe for breast cancer patients experiencing hair loss. Studies have found that it does not interfere with cancer treatments and is well-tolerated, with no major side effects reported. The FDA has already approved minoxidil for treating hair loss, which further assures its safety.

For low-level red-light therapy, research indicates it is safe, with only minor side effects. This therapy is also FDA-approved for hair loss and is safe for various skin conditions. It uses light that does not harm DNA.

Overall, both minoxidil and low-level red-light therapy are considered safe options for hair regrowth in breast cancer patients.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for hair loss in breast cancer patients because they combine familiar therapies in a novel way. Minoxidil, already well-known for its effectiveness in treating hair loss by promoting blood flow to hair follicles, is used in both treatment groups. The unique aspect is the addition of low-level red-light therapy (LLLT) in the second group, which uses the Revian RED LED-light cap. This approach potentially enhances hair regrowth by stimulating cellular activity and reducing inflammation, offering a dual-action treatment that could be more effective than minoxidil alone.

What evidence suggests that this trial's treatments could be effective for chemotherapy-induced hair loss?

Research has shown that minoxidil, which participants in this trial may receive, can help treat hair loss. In studies, many people using minoxidil have experienced moderate to significant improvement in hair thickness. Minoxidil boosts blood flow to the scalp and encourages hair follicles to move from a resting phase to an active growth phase.

Low-level red-light therapy (LLLT) is another treatment option in this trial and has also shown promise in studies for encouraging hair growth. When red light reaches the skin, it can activate hair follicles and help hair grow. Some studies suggest that using minoxidil together with red-light therapy might be more effective than using minoxidil alone for hair loss caused by chemotherapy.23678

Who Is on the Research Team?

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Brittany L Dulmage, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with breast cancer (any stage) treated at Ohio State University who lost at least half their scalp hair after chemotherapy with anthracyclines or taxanes. Participants can't be pregnant, nursing, have certain types of hair loss, a known allergy to minoxidil, or be on immunotherapy.

Inclusion Criteria

* Patients will NOT have a known sensitivity to minoxidil
* Patients will NOT be pregnant or nursing women
There is no specific eligibility requirement stated here.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive minoxidil topically to the scalp daily, with or without low-level red-light therapy, for 6 months

6 months
Daily application

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Visits at 2, 4, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Low-Level Red-Light Therapy
  • Minoxidil

Trial Overview

The study compares using topical minoxidil alone versus minoxidil plus a red-light therapy cap to see which works better and is safer for treating chemotherapy-related hair loss in breast cancer patients.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (minoxidil, LLLT)Experimental Treatment4 Interventions
Group II: Arm I (minoxidil)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Citations

The effect of a helmet type, home-use low-level light therapy ...

This study determines the efficacy of low-level light therapy for the prevention of chemotherapy-induced hair loss for patients with breast cancer

Minoxidil With or Without Low-Level Red-Light Therapy for ...

Combining minoxidil with low-level red-light therapy may be safe and more effective at improving chemotherapy-induced alopecia than minoxidil ...

Red light therapy: What the science says - Stanford Medicine

Instead, they found that those receiving red light treatment sprouted more hair. Additional studies — in mice and in humans — bolstered evidence ...

Low-Level Laser (Light) Therapy (LLLT) for Treatment of Hair ...

Studies have shown that LLLT stimulated hair growth in mice subjected to chemotherapy-induced alopecia and also in alopecia areata. Controlled clinical trials ...

Clinical Results

Participants who were treated with the red light therapy and were at least 80% compliant for the duration of the study had an average of 26.3 more hairs per cm² ...

Examining the Safety and Efficacy of Low-Level Laser ... - PMC

These laser devices have good safety profiles, with only minor adverse effects reported. However, physicians should be cautious when drawing ...

Minoxidil + Red-Light Therapy for Hair Loss in Breast Cancer

Low-level light therapy is regarded as a safe and medically accepted treatment for a variety of skin conditions, including acne, scars, and ...

A Systematic Review and Meta-analysis of Randomized ...

This review article examines the literature on FDA-approved Low-Level Light/Laser Therapy devices for treating pattern hair loss.