What is the mechanism of action of this treatment?

Minoxidil, a common treatment for hair loss, works by prolonging the anagen (growth) phase of hair follicles and increasing blood flow to the scalp, which helps to stimulate hair growth and reduce hair loss. This is particularly important for patients as it can improve hair density and overall appearance, thereby enhancing quality of life and self-esteem. Other treatments, such as finasteride, work by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a hormone that shrinks hair follicles. Understanding these mechanisms helps patients and clinicians choose the most appropriate treatment based on the underlying cause of hair loss.

What side effects are associated with this type of intervention?

Minoxidil, used both topically and orally, is a common treatment for hair loss. Known side effects of topical minoxidil include scalp irritation, itching, and dryness. Oral minoxidil can cause more systemic side effects such as low blood pressure, dizziness, and fluid retention. Hydroxychloroquine, another treatment option, has been reported to be ineffective in some cases and may cause side effects like gastrointestinal discomfort and retinal toxicity. Combination therapies, such as tofacitinib with oral minoxidil, may offer benefits but also carry risks of compounded side effects from each medication.

What prior FDA approvals exist?

Minoxidil is a well-known FDA-approved treatment for hair loss, available in both topical and oral forms. It is commonly used to treat androgenetic alopecia and has shown efficacy in promoting hair growth and reducing hair loss. Another FDA-approved treatment for hair loss is finasteride, which is used primarily in men for androgenetic alopecia. Additionally, bimatoprost has been studied for chemotherapy-induced eyelash hypotrichosis, although its preventive benefits and safety during chemotherapy are not well established. These treatments highlight the FDA's focus on addressing various forms of hair loss through different mechanisms.

What other types of research exist?

Promising novel alternatives to Minoxidil for hair loss treatment include: 1) Janus kinase (JAK) inhibitors such as oral ruxolitinib, which has shown significant hair regrowth in patients with alopecia areata. 2) Combination therapies like tofacitinib and oral minoxidil, which have been effective in severe cases. 3) Low-dose recombinant interleukin 2 to promote T-regulatory cells, showing potential in alopecia areata. 4) Hydroxychloroquine, although results are mixed, it has shown success in some cases of alopecia totalis. 5) Topical bimatoprost for chemotherapy-induced eyelash alopecia, though more data is needed for broader applications.

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Vasodilator

Topical or Oral Minoxidil for Hair Loss from Breast Cancer Treatment

Phase < 1

Recruiting

Led By Brittany L Dulmage, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Established diagnosis of breast cancer stages I-IV

Self-reporting hair loss since starting endocrine therapy

Must not have

Prior use of oral or topical minoxidil

Current chemotherapy use or prior chemotherapy use within the last 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial studies the effects of minoxidil, either as a foam applied to the scalp or taken as a pill, in breast cancer patients who lose hair due to their treatment. The goal is to see if minoxidil can help regrow hair and improve their quality of life. Minoxidil has been shown to be effective for different types of hair loss and has been used in various forms to treat this condition.

Who is the study for?

This trial is for women aged 18 or older with stage I-IV breast cancer who are experiencing hair loss since starting endocrine therapy, including tamoxifen or aromatase inhibitors. It's not suitable for pregnant/nursing women, those on recent chemotherapy, with certain types of alopecia, untreated thyroid/iron issues, prior minoxidil use, or a known sensitivity to it.

What is being tested?

The study is testing whether topical or oral Minoxidil can help treat hair loss caused by endocrine therapy in breast cancer patients. The trial includes questionnaires and quality-of-life assessments to evaluate the effectiveness and side effects of the treatment.

What are the potential side effects?

Minoxidil may cause scalp irritation when applied topically and could potentially lead to unwanted facial/body hair growth. Oral Minoxidil might result in systemic side effects like changes in blood pressure or heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with breast cancer at any stage.

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I have experienced hair loss since starting hormone therapy.

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I am currently on hormone therapy for my cancer.

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I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have used minoxidil, either as a pill or applied to the skin.

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I have used chemotherapy in the past 2 years or am currently using it.

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I have a history of scarring hair loss or patchy hair loss.

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I have used or am using spironolactone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of days assigned medication was taken/applied

Secondary study objectives

CADS score emotional

CADS score physical

Change in hair density

+3 more

Side effects data

From 2015 Phase 2 trial • 21 Patients • NCT00876200

56%

Hypertrichosis

11%

Strabismus correction

100%

80%

60%

40%

20%

Study treatment Arm

Minoxidil

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (orally minoxidil)Experimental Treatment3 Interventions

Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (topical minoxidil)Active Control3 Interventions

Patients apply minoxidil foam topically to affected areas of the scalp QD for up to 12 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Minoxidil

FDA approved

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Minoxidil, a common treatment for hair loss, works by prolonging the anagen (growth) phase of hair follicles and increasing blood flow to the scalp, which helps to stimulate hair growth and reduce hair loss. This is particularly important for patients as it can improve hair density and overall appearance, thereby enhancing quality of life and self-esteem. Other treatments, such as finasteride, work by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a hormone that shrinks hair follicles. Understanding these mechanisms helps patients and clinicians choose the most appropriate treatment based on the underlying cause of hair loss.