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

Phase 2

Recruiting

• Conditions: Survivors of Childhood Cancer; Alopecia
• Interventions: Drug: Oral Minoxidil; Other: Placebo

• Registration Number: NCT05778825
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-10
• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo followed by oral Minoxidil	Oral Minoxidil	Patient receive placebo for 4 months followed by oral minoxidil for 4 months
Oral Minoxidil	Oral Minoxidil	Patients receive oral minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months
Placebo followed by oral Minoxidil	Placebo	Patient receive placebo for 4 months followed by oral minoxidil for 4 months

Primary Outcome Measures

Name	Time	Method
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density	at 8 months	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States