Oral Minoxidil for Chemotherapy-Induced Alopecia

Overseen By DermCTU

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Anticoagulants, Guanethidine, Hypotensive drugs

Disqualifiers: Pheochromocytoma, Hypothyroidism, Anemia, others

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

Compensation: Varies

Number of Visits: 12

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether low-dose oral minoxidil can treat permanent hair loss caused by chemotherapy. The study will evaluate the treatment's effectiveness for individuals who completed chemotherapy at least six months ago. It seeks participants diagnosed with permanent chemotherapy-induced hair loss. Those who have experienced this type of hair loss and finished chemotherapy more than six months ago may find this trial suitable. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you are taking certain drugs that affect blood pressure or are on guanethidine without a 1-week break. If you're on any listed medications, further evaluation is needed to determine eligibility.

Is there any evidence suggesting that oral minoxidil is likely to be safe for humans?

Previous studies have found low-dose oral minoxidil to be generally safe for treating hair loss. Research shows that side effects are rare, with only about 1.7% of patients discontinuing use due to them. This indicates that most people tolerate it well. However, while it is considered safe for hair loss, its safety during chemotherapy remains uncertain. Consulting a healthcare provider is important to understand the potential risks and benefits for each specific situation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Oral minoxidil is unique because it offers a new approach to treating chemotherapy-induced alopecia by using an oral delivery method rather than topical applications. While most current treatments involve topical solutions or wigs to manage hair loss, oral minoxidil targets the problem systemically, potentially promoting hair growth from the inside out. Researchers are excited because this could mean more consistent and effective results for patients, offering a simpler and potentially more reliable solution to hair loss during chemotherapy.

What evidence suggests that oral minoxidil might be an effective treatment for chemotherapy-induced alopecia?

Research has shown that oral minoxidil may help with hair loss caused by chemotherapy. Some patients have experienced positive results with hair regrowth. In this trial, participants will receive a low dose of oral minoxidil. Studies indicate that this can either promote hair regrowth or prevent further hair loss in individuals with this condition. Early reports suggest this treatment might be effective for both the front and back of the head. Although more research is needed, these initial findings offer promise for those experiencing hair loss from chemotherapy. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer N Choi, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with permanent hair loss from chemotherapy, finished at least 6 months ago. They must not be pregnant or nursing, agree to use contraception, and have no history of certain conditions like hypotension or hypersensitivity to the drug's components. Those on other alopecia treatments within the last 3 months or current cancer treatment are excluded.

Inclusion Criteria

I agree to use birth control during and for 30 days after the study.

I have permanent hair loss from chemotherapy that ended over 6 months ago.

Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Exclusion Criteria

I have not used any experimental drugs or alopecia treatments in the last 3 months.

I am not on blood thinners, so I can participate in the optional biopsy.

I can communicate and cooperate with my doctor without issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low dose oral minoxidil for the treatment of permanent chemotherapy-induced alopecia

48 weeks

Visits every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oral Minoxidil

Trial Overview

The study tests low-dose oral minoxidil for treating permanent hair loss caused by chemotherapy. It's an open-label pilot study, meaning both researchers and participants know what treatment is being given without any comparison group.

How Is the Trial Designed?

Group I: Minoxidil Treatment Experimental Treatment 1 Intervention

Low dose oral minoxidil

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

In a study involving 48 female cancer patients undergoing doxorubicin-based chemotherapy, the 2% topical solution of minoxidil was found to be non-toxic, showing no adverse effects.

However, minoxidil did not effectively prevent severe hair loss (alopecia) during chemotherapy, as 88% of patients in the minoxidil group and 92% in the placebo group experienced severe hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minoxidil (Mx) as a prophylaxis of doxorubicin--induced alopecia. Rodriguez, R., Machiavelli, M., Leone, B., 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]

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]

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]

A rare case of inferior hemiretinal artery occlusion was reported in a 21-year-old male who had been using topical 5% minoxidil for androgenic alopecia for 3 years, highlighting a potential ocular side effect of this commonly used treatment.

While no direct cause-and-effect relationship was established between minoxidil use and the retinal occlusion, healthcare providers should be aware of this possible risk when treating patients with topical minoxidil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal artery occlusion as a probable idiosyncratic reaction to topical minoxidil: a case report. Venkatesh, R., Pereira, A., Reddy, NG., et al.[2021]

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

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These records showed that all women taking LDOM either experienced improvement in their hair growth or stabilization of their hair loss within 3 ...

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Low-dose oral minoxidil is an effective and safe treatment alternative for a variety of hair loss disorders in healthy patients having difficulties with topical ...