Oral Minoxidil for Hair Loss in Childhood Cancer Survivors

Overseen By Danielle Friedman, MD, MS

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Alopecia therapies, Anticancer therapies

Disqualifiers: Scalp disorders, Hypotension, Cardiovascular disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test whether minoxidil taken by mouth (oral minoxidil) can improve hair loss caused by cancer treatment in children and young adults. In addition, the researchers will test the safety of oral minoxidil, and see if the study drug causes few or mild side effects in participants. Other purposes of this study include looking at whether participants are able to follow their study drug dosing schedules, and how oral minoxidil affects participants' quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use other therapies for hair loss while participating.

What evidence supports the effectiveness of the drug oral minoxidil for hair loss in childhood cancer survivors?

Oral minoxidil is known to cause hair growth as a side effect when used for high blood pressure, and topical minoxidil has been effective for certain types of hair loss like androgenetic alopecia. However, there is limited direct evidence of its effectiveness for hair loss in childhood cancer survivors. ^{1 2 3 4 5}

Is oral minoxidil safe for children?

Oral minoxidil has been used in children, and while it can cause mild side effects like extra hair growth, it is generally well-tolerated. High doses can lead to more noticeable side effects, but no severe issues were reported in studies. ^{1 2 4 6 7}

How does the drug oral minoxidil differ from other treatments for hair loss in childhood cancer survivors?

Oral minoxidil is unique because it is taken by mouth, unlike the more common topical minoxidil applied directly to the scalp. It was originally used to treat high blood pressure, but it can also promote hair growth, making it a novel option for hair loss in children who have survived cancer. ^{1 2 4 8 9}

Research Team

Alina K Markova, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for children and young adults aged 6-18 who are cancer survivors with hair loss related to past chemotherapy or radiation. They must have finished their cancer treatment at least a year ago, not be on other alopecia treatments, and can't have low blood pressure or certain heart conditions.

Inclusion Criteria

I finished my cancer treatment (chemotherapy or radiation) over a year ago.

I have had hair loss for over 6 months due to past cancer treatment.

I was diagnosed with cancer before turning 17.

Exclusion Criteria

I am not currently on any cancer treatments like chemotherapy or immunotherapy.

I have a history of fainting or low blood pressure.

My blood pressure is below 90/50 mmHg.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral minoxidil or placebo for hair loss treatment

8 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Oral Minoxidil
• Placebo

Trial Overview The study is testing if oral Minoxidil helps improve hair growth in young cancer survivors compared to a placebo. It will also assess the drug's safety, adherence to dosing schedules by participants, and its impact on their quality of life.

Participant Groups

Group I: Oral Minoxidil Experimental Treatment 1 Intervention

Patients receive oral minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months

Group II: Placebo followed by oral Minoxidil Active Control 2 Interventions

Patient receive placebo for 4 months followed by oral minoxidil for 4 months

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

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]

In a study comparing hair loss after different treatment approaches for medulloblastoma, 70% of patients receiving chemotherapy followed by craniospinal radiotherapy (C-CSRT) experienced hair loss in the cranial field, compared to only 30% in those who had surgery followed by craniospinal radiotherapy (CSRT).

Age was found to significantly influence the extent of hair loss, highlighting that persistent hair loss is a notable late effect of treatment that can impact patients' quality of life and should be considered in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of permanent hair loss in children with standard risk PNETS of the posterior fossa following radiotherapy alone or chemotherapy and radiotherapy after surgical resection. Rogers, S., Donachie, P., Sugden, E., et al.[2011]

In a study of 20 pediatric patients aged 2 months to 13 years who received high doses of oral minoxidil, 65% experienced hypertrichosis (excessive hair growth), typically starting around 24 days after treatment began.

While 15% of the patients showed systemic effects from the medication, none experienced severe disorders, indicating that while side effects can occur, they may not be life-threatening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic Minoxidil Accidental Exposure in a Paediatric Population: A Case Series Study of Cutaneous and Systemic Side Effects. Sánchez-Díaz, M., López-Delgado, D., Montero-Vílchez, T., 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]

A review of 63 pediatric patients (ages 0-12) treated with low-dose oral minoxidil (LDOM) or sublingual minoxidil (SM) showed that these treatments were generally well-tolerated, with mild hypertrichosis being the most common side effect.

There is currently a lack of recommended treatment guidelines for the use of minoxidil in children, highlighting the need for further large-scale studies to assess its efficacy and optimal dosage for treating alopecia in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic minoxidil for hair disorders in pediatric patients: a safety and tolerability review. John, JM., Sinclair, RD.[2023]

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 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]

Topical minoxidil (TMX) is commonly used for treating hair loss in children, but it is not FDA-approved for those under 18, and there are no established guidelines for its use in pediatric patients.

Oral minoxidil (OMX) has been used off-label in very low doses for hair loss in children, but dermatologists should be cautious of potential systemic absorption risks, as there is no consensus on the appropriate dosing or minimum age for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical and oral minoxidil for hair disorders in pediatric patients: What do we know so far? Lemes, LR., Melo, DF., de Oliveira, DS., et al.[2021]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

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

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

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

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

Comparison of permanent hair loss in children with standard risk PNETS of the posterior fossa following radiotherapy alone or chemotherapy and radiotherapy after surgical resection. [2011]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Systemic Minoxidil Accidental Exposure in a Paediatric Population: A Case Series Study of Cutaneous and Systemic Side Effects. [2021]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Systemic minoxidil for hair disorders in pediatric patients: a safety and tolerability review. [2023]

7. India pubmed.ncbi.nlm.nih.gov

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

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

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

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

Topical and oral minoxidil for hair disorders in pediatric patients: What do we know so far? [2021]