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Trial Title:
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors
NCT ID:
NCT05778825
Condition:
Survivors of Childhood Cancer
Alopecia
Conditions: Official terms:
Alopecia
Alopecia Areata
Minoxidil
Conditions: Keywords:
Hair loss
Minoxidil
23-022
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Oral Minoxidil
Description:
minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day
Arm group label:
Oral Minoxidil
Arm group label:
Placebo followed by oral Minoxidil
Intervention type:
Other
Intervention name:
Placebo
Description:
placebo for 4 months
Arm group label:
Placebo followed by oral Minoxidil
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.
Criteria for 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
Gender:
All
Minimum age:
6 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alina Markova, MD
Phone:
646-608-2342
Contact backup:
Last name:
Danielle Friedman, MD
Phone:
212-639-7376
Investigator:
Last name:
Alina Markova, MD
Email:
Principal Investigator
Start date:
March 10, 2023
Completion date:
March 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05778825
http://www.mskcc.org/mskcc/html/44.cfm
