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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05778825

Collaborator

(none)

Enrollment

Location

Arms

35.7

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Survivors of Childhood Cancer Alopecia	Drug: Oral Minoxidil Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 10, 2023

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Oral Minoxidil

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

Drug: Oral Minoxidil

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

Active Comparator: Placebo followed by oral Minoxidil

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

Drug: Oral Minoxidil

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

Other: Placebo

placebo for 4 months

Outcome Measures

Primary Outcome Measures

change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density [at 4 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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