Topical or Oral Minoxidil for Hair Loss from Breast Cancer Treatment

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Ohio State University Comprehensive Cancer Center

Must be taking: Endocrine therapy

Must not be taking: Chemotherapy, Spironolactone

Disqualifiers: Pregnancy, Scarring alopecia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well minoxidil, a drug known for promoting hair growth, works for women experiencing hair loss due to breast cancer treatment. It examines two methods of using minoxidil: one group applies it as a foam to the scalp, while the other takes it as a pill. Women experiencing hair thinning since starting endocrine therapy for breast cancer may qualify for this study. The goal is to determine if minoxidil can reduce hair loss and improve life quality for those affected. As an Early Phase 1 trial, this research aims to understand how minoxidil works in people, offering participants a chance to contribute to groundbreaking insights.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are currently using chemotherapy, spironolactone, or have used minoxidil before.

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

Research shows that both topical and oral minoxidil have undergone safety studies. The FDA approved topical minoxidil in 1988 for treating hair loss, indicating long-term use without major safety concerns. Studies have found it safe and effective for both men and women with hair loss.

For oral minoxidil, research suggests it is generally well-tolerated at low doses. Studies on breast cancer survivors indicate it can be safe for treating hair loss, even for those who have had treatments affecting the heart. However, since this is an early phase trial, researchers are still closely examining its safety for hair loss caused by hormone treatments.

In summary, both forms of minoxidil have a history of safety for hair loss, but this trial is crucial to confirm their safety specifically for breast cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using minoxidil for hair loss caused by breast cancer treatment because it offers two unique delivery methods: topical and oral. Unlike standard options like wigs or scalp cooling caps, topical minoxidil is directly applied to the scalp, which might stimulate hair growth at the roots. The oral form provides an internally systemic approach, potentially offering convenience and effectiveness for those who prefer taking a pill. Both methods leverage minoxidil's known ability to promote hair growth, providing new hope for patients seeking to combat hair loss during a challenging time.

What evidence suggests that minoxidil could be effective for treating hair loss from breast cancer treatment?

This trial will compare the effectiveness of topical versus oral minoxidil for hair loss caused by breast cancer treatments. Research has shown that minoxidil, available as a lotion or pill, may help with hair loss. Participants in this trial will either apply minoxidil foam topically or take it orally. Studies have found that low doses of oral minoxidil can help most breast cancer patients regrow hair. Specifically, one study found that 87.1% of patients using minoxidil lotion experienced noticeable hair growth. While evidence for both forms of minoxidil is promising, results can vary among individuals. Minoxidil likely works by increasing blood flow to hair roots, which may promote hair growth. ^{1 3 6 7 8}

Who Is on the Research Team?

Brittany L Dulmage, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with breast cancer at any stage.

I have experienced hair loss since starting hormone therapy.

I am currently on hormone therapy for my cancer.

Exclusion Criteria

You are allergic to minoxidil.

Pregnant or nursing women

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either topical or oral minoxidil daily for up to 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Minoxidil

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm II (orally minoxidil) Experimental Treatment 3 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 Control 3 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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

In a pilot study involving 10 women undergoing chemotherapy for gynecologic cancers, 2% topical Minoxidil was found to be non-toxic and did not cause any side effects, such as skin changes or hypotension.

Despite its known efficacy in treating male pattern baldness, Minoxidil showed no significant benefit in preventing hair loss during chemotherapy, as 5 out of 6 evaluable patients experienced severe hair loss within four weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of minoxidil to attempt to prevent alopecia during chemotherapy for gynecologic malignancies. Granai, CO., Frederickson, H., Gajewski, W., et al.[2020]

In a study involving 22 women undergoing chemotherapy, topical minoxidil significantly reduced the time from maximum hair loss to the first signs of hair regrowth, shortening the baldness period by an average of 50.2 days.

The use of minoxidil was found to be safe, with no significant side effects reported, making it a promising option for managing chemotherapy-induced hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of minoxidil in chemotherapy-induced alopecia. Duvic, M., Lemak, NA., Valero, V., et al.[2013]

Minoxidil is an FDA-approved topical treatment for hair loss in both men and women, available in 2% and 5% formulations, and is generally considered safe but should be used with caution due to potential side effects.

A case of non-arteritic anterior ischemic optic neuropathy was reported in a patient using 5% minoxidil, which resolved after stopping the treatment, highlighting the need for awareness of rare but serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could Topical Minoxidil Cause Non-Arteritic Anterior Ischemic Optic Neuropathy? Aktas, H., Alan, S., Türkoglu, EB., et al.[2020]

Men with breast cancer should undergo mastectomy as the primary surgical treatment, and decisions regarding additional systemic treatments should be based on factors similar to those used for women, including tumor size and hormone receptor status.

Hormonal therapy is crucial for treating hormone receptor-positive breast cancer in men, with tamoxifen as the first-line treatment, while newer aromatase inhibitors may also be effective, and options like orchiectomy or LHRH agonists are available for second-line therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Male breast cancer. Volm, MD.[2022]

Persistent or permanent hair loss can occur in breast cancer patients after treatment with taxane chemotherapy and endocrine therapy, as demonstrated in a case study of a 59-year-old woman.

Topical minoxidil therapy showed significant clinical improvement for the patient's alopecia, suggesting it may be a reasonable treatment option for hair loss in breast cancer patients following chemotherapy or hormonal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent Alopecia in a Breast Cancer Patient Following Taxane Chemotherapy and Adjuvant Endocrine Therapy: Case Report and Review of Post-treatment Hair Loss in Oncology Patients with Breast Cancer. Werbel, T., Cohen, PR.[2020]

Citations

1. nyulangone.org nyulangone.org/news/hair-growth-drug-safe-low-doses-breast-cancer-patients

Hair Growth Drug Safe at Low Doses for Breast Cancer ... A study in women with breast cancer suggests that low oral doses of minoxidil, taken during or after cancer treatment, appear to regrow hair in most patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12503880/

Low-Dose Oral Minoxidil during Chemotherapy: A Review ... There is currently no evidence to support the use of minoxidil as a treatment for cancer, but these preclinical findings do at the very least suggest that LDOM ...

3. rheumatologyadvisor.com rheumatologyadvisor.com/news/low-dose-oral-minoxidil-effective-for-alopecia-in-breast-cancer/

Low-Dose Oral Minoxidil Effective for Alopecia in Breast ... After three to six months of taking LDOM, all patients had improvement or stability of alopecia; no significant difference was seen in the ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT366066

Oral minoxidil for the treatment of late alopecia in cancer ... Conclusions: Oral minoxidil may benefit both frontal and occipital late alopecia in cancer survivors treated with cytotoxic and/or endocrine therapy. This ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0001731025003783

[Translated article] High-dose Oral Minoxidil for the ... Results showed an overall improvement in hair density between 10–30% in most patients, although with variable responses. A total of 17.5% of patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408754/

Cancer-Related Alopecia Risk and Treatment - PMC A single-blind study found that 80% of breast cancer patients who used 5% topical minoxidil showed a moderate to significant improvement in ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05417308?term=U-10858&rank=1

Study Details | NCT05417308 | Topical or Oral Minoxidil for ... Oral minoxidil may increase hair density in women with EIA, and work the same as topical minoxidil in treating EIA in patients with breast cancer. Detailed ...

8. healio.com healio.com/news/dermatology/20250108/hair-is-identity-lowdose-oral-minoxidil-treats-hair-loss-in-breast-cancer-survivors

'Hair is identity': Low-dose oral minoxidil treats hair loss in ... This study supports the safety of LDOM for the treatment of hair loss in breast cancer survivors, including those who used cardiotoxic drugs.