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

Trial Summary

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.

What data supports the effectiveness of the drug Minoxidil for hair loss from breast cancer treatment?

Topical minoxidil has shown significant improvement in hair regrowth for a breast cancer patient who experienced hair loss after chemotherapy and hormonal therapy. Additionally, it is known to be effective for male and female pattern hair loss, although its effectiveness for preventing chemotherapy-induced hair loss is not well-supported. ^{1 2 3 4 5}

Is minoxidil safe for humans?

Topical minoxidil is generally considered safe for humans, with common side effects limited to skin irritation or allergic reactions on the scalp. Oral minoxidil, used for severe high blood pressure, can cause faster heart rate and water retention, so it should be used with caution. ^{1 2 4 5 6}

How does the drug Minoxidil differ from other treatments for hair loss caused by breast cancer therapy?

Minoxidil is unique because it can be applied topically or taken orally, offering flexibility in administration. Unlike other treatments that may involve hormonal components, Minoxidil works by directly stimulating hair growth without affecting hormone levels, making it a potentially safer option for patients undergoing breast cancer treatment. ^{7 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Brittany L Dulmage, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States 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. [2020]

2. Singapore pubmed.ncbi.nlm.nih.gov

The use of minoxidil to attempt to prevent alopecia during chemotherapy for gynecologic malignancies. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of low-dose oral minoxidil versus topical solution in the improvement of androgenetic alopecia: A randomized controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The therapeutic use of topical minoxidil. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of minoxidil in chemotherapy-induced alopecia. [2013]

6. India pubmed.ncbi.nlm.nih.gov

Could Topical Minoxidil Cause Non-Arteritic Anterior Ischemic Optic Neuropathy? [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical aspect, pathogenesis and therapy options of alopecia induced by hormonal therapy for breast cancer. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of 5α-reductase inhibitors and spironolactone in breast cancer patients receiving endocrine therapies. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Novel routes for administering chemoprevention: local transdermal therapy to the breasts. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Male breast cancer. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Male breast cancer. [2022]