This phase II trial tests the safety of minoxidil and how well it works in treating therapy-related hair loss (alopecia) that has continued for longer than 6 months (persistent) in pediatric and young adult cancer survivors. Persistent alopecia can occur after radiation and / or chemotherapy due to damage to hair follicles. Persistent hair loss is rarely included as an adverse event in clinical trials and is often under-recognized by healthcare providers. Persistent hair loss has a negative effect on the quality of life among childhood cancer survivors. Studies in children and adults with different types of hair loss have shown that minoxidil can help with hair growth. Minoxidil is a drug that may increase blood flow to hair follicles and stimulate hairs to grow. Minoxidil that is put on the skin is routinely used for hair loss in cancer survivors, however, some patients find it requires a long time to apply each day and some areas of the scalp may get missed. Taking minoxidil by mouth (orally) may make it easier to take daily and avoids the problem of missing areas of the scalp as well as possible skin irritation from the application. Giving minoxidil may increase hair growth and may improve quality of life in pediatric and young adult cancer survivors.
Additional locations may be listed on ClinicalTrials.gov for NCT05778825.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Alina Markova
Phone: 646-608-2342
PRIMARY OBJECTIVE:
I. To estimate the percent change in target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density (number of hairs/cm^2) as assessed by trichoscopy in patients with persistent alopecia receiving oral minoxidil and those receiving placebo at 4 months.
SECONDARY OBJECTIVES:
I. To evaluate target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density (number of hairs/ cm^2) as assessed by trichoscopy at eight months for patients randomized to oral minoxidil (baseline to eight months) and patients randomized to the placebo (four months to eight months).
II. Evaluate the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair thickness (shaft diameter) as assessed by trichoscopy at four months for patients randomized to oral minoxidil versus placebo followed by oral minoxidil (baseline to four months) and at eight months for patients randomized to oral minoxidil (baseline to eight months) versus placebo (four months to eight months).
III. Evaluate the target area (2/3 of the distance midline from glabella to occiput from the front toward the back) hair density (# hairs/ cm^2) and hair thickness (shaft diameter) as assessed by trichoscopy at four months for patients randomized to oral minoxidil versus placebo followed by oral minoxidil (baseline to four months) and at eight months for patients randomized to oral minoxidil (baseline to eight months) versus placebo (four months to eight months).
IV. Evaluate the safety, tolerability and degree of toxicity of oral minoxidil as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
V. Determine adherence to oral minoxidil through patient diaries.
VI. Determine the change in alopecia graded using CTCAE version (v)5.0 and severity of alopecia tool (SALT) at 4 and 8 months.
VII. Determine the change in alopecia as reported by the patient/ family using the 7-point global assessment scale (GAS) at four and eight months compared to baseline.
VIII. Determine the effect of oral minoxidil on patient reported alopecia specific quality of life as determined by the dermatology life quality index (Cartoon DLQI for children 6-11 years old, Children’s DLQI for patients 12-15 years old, and DLQI for patients 16 years and older).
IX. Determine differences in efficacy and tolerability between patients with and without prior radiation therapy (RT).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive minoxidil orally (PO) once daily (QD) for 8 months on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 4 months followed by minoxidil PO for 4 months on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 12 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAlina Markova
