A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of Oral Minoxidil for the Treatment of Persistent Hair Loss in Pediatric, Adolescent, and Young Adult Cancer Survivors

Conditions
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Survivors of Childhood Cancer, Alopecia

Intervention / Treatment
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* Drug: Oral Minoxidil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have been diagnosed with cancer before the age of 17. They must have completed either systemic or radiation therapy (cytotoxic chemotherapy and external beam radiation therapy) for their cancer at least 1 year prior to study entry. They must be between 6-18 years old at the time of enrollment. They must have a clinical diagnosis of persistent or late alopecia for >6 months and that is definitely, probably, or possibly related to prior chemotherapy and/or radiation. Exclusion Criteria: Had a history of alopecia prior to systemic or radiation therapy for cancer, or has alopecia unrelated to cancer treatment. Have scalp disorders that preclude the evaluation of alopecia, such as psoriasis Has a known hypersensitivity to minoxidil Concurrent use of other therapies for alopecia Concurrent active anticancer therapies (cytotoxic, targeted, endocrine, immunologic) History of chronic sclerotic cutaneous GvHD affecting the scalp Active chronic cutaneous GvHD History of orthostatic or symptomatic hypotension, syncope related to hypotension; systolic less than or equal than 100 (for adults) and 90 (for children) at screening. Pregnancy. Cardiovascular disease that in the opinion of the cardiologist makes the patient unsuitable for therapy Blood pressure less than the 5th percentile or less than 90/50 mmHg for children 10 years or older

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Minoxidil<br>Patients receive oral minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months | Drug: Oral Minoxidil<br>* minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day<br>|
| Active Comparator: Placebo followed by oral Minoxidil<br>Patient receive placebo for 4 months followed by oral minoxidil for 4 months | Drug: Oral Minoxidil<br>* minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day<br>Other: Placebo<br>* placebo for 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density | as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements. | at 4 months | 
| change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density | as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements. | at 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hair loss, Minoxidil, 23-022