Clinical trial NCT05778825: A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors
Official title: A Pilot Study of Oral Minoxidil for the Treatment of Persistent Hair Loss in Pediatric, Adolescent, and Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Survivors of Childhood Cancer
Alopecia
Keywords: Hair loss
Minoxidil
23-022
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
timeFrame: at 4 months
measure: change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
timeFrame: at 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alina Markova, MD
role: PRINCIPAL_INVESTIGATOR
References: