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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2026-03-31

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.

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Detailed Description

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Conditions

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Survivors of Childhood Cancer Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oral Minoxidil

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

Group Type EXPERIMENTAL

Oral Minoxidil

Intervention Type DRUG

minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day

Placebo followed by oral Minoxidil

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

Group Type ACTIVE_COMPARATOR

Oral Minoxidil

Intervention Type DRUG

minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day

Placebo

Intervention Type OTHER

placebo for 4 months

Interventions

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Oral Minoxidil

minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day

Intervention Type DRUG

Placebo

placebo for 4 months

Intervention Type OTHER

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No