Alopecia, Survivors of Childhood Cancer
Conditions
Keywords
Hair loss, Minoxidil, 23-022
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.
Interventions
DRUGOral Minoxidil
minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day
OTHERPlacebo
placebo for 4 months
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlina Markova, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed