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

14 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug oral minoxidil for chemotherapy-induced alopecia?

There is a case report of a woman experiencing significant hair regrowth after using oral minoxidil for permanent chemotherapy-induced alopecia, suggesting potential effectiveness. Additionally, topical minoxidil has shown improvement in hair loss for a breast cancer patient after chemotherapy, indicating that minoxidil may help with hair regrowth in similar contexts. ^{1 2 3 4 5}

Is oral minoxidil safe for humans?

Minoxidil, commonly used as a topical solution for hair loss, is generally considered safe, but it can cause side effects like faster heart rate and water retention when taken orally. Topical minoxidil has been associated with rare eye-related side effects, but no serious side effects were reported in a study using it for chemotherapy-induced hair loss. ^{2 3 6 7 8}

How does the drug oral minoxidil differ from other treatments for chemotherapy-induced alopecia?

Oral minoxidil is unique because it is taken by mouth, unlike the more common topical minoxidil applied directly to the scalp. It is being explored for chemotherapy-induced alopecia, especially in cases where hair loss is permanent and does not respond to standard treatments like scalp cooling or topical minoxidil. ^{1 2 3 4 9}

What is the purpose of this trial?

This trial is testing a low dose of oral minoxidil to help people who have lost their hair permanently due to chemotherapy. The goal is to see if this medication can safely and effectively promote hair regrowth and improve patients' quality of life. Oral minoxidil has been proposed as a safe alternative to topical minoxidil for treating hair loss, showing efficacy in various studies.

Research Team

Jennifer N Choi, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Minoxidil (Mx) as a prophylaxis of doxorubicin--induced alopecia. [2020]

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

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

3. 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]

4. Australia pubmed.ncbi.nlm.nih.gov

Treatment of permanent chemotherapy-induced alopecia with low dose oral minoxidil. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Preventive effects of cedrol against alopecia in cyclophosphamide-treated mice. [2019]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Retinal artery occlusion as a probable idiosyncratic reaction to topical minoxidil: a case report. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Oral Minoxidil 5 mg Once Daily in the Treatment of Male Patients with Androgenetic Alopecia: An Open-Label and Global Photographic Assessment. [2020]