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Vasodilator

Oral Minoxidil for Hair Loss in Childhood Cancer Survivors

Phase 2
Recruiting
Led By Mario Lacouture, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Must not have
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.
Concurrent active anticancer therapies (cytotoxic, targeted, endocrine, immunologic)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 months

Summary

This trial will test if a drug can improve hair loss caused by cancer treatment in kids and young adults. Safety, dosing & quality of life will be monitored.

Who is the study for?
This trial is for children and young adults aged 6-18 who are cancer survivors with hair loss related to past chemotherapy or radiation. They must have finished their cancer treatment at least a year ago, not be on other alopecia treatments, and can't have low blood pressure or certain heart conditions.
What is being tested?
The study is testing if oral Minoxidil helps improve hair growth in young cancer survivors compared to a placebo. It will also assess the drug's safety, adherence to dosing schedules by participants, and its impact on their quality of life.
What are the potential side effects?
Possible side effects of oral Minoxidil may include changes in blood pressure, heart rate alterations, scalp irritation, unwanted facial/body hair growth. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I finished my cancer treatment (chemotherapy or radiation) over a year ago.
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I am between 6 and 18 years old.
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I was diagnosed with cancer before turning 17.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of fainting or low blood pressure.
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I am not currently on any cancer treatments like chemotherapy or immunotherapy.
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My blood pressure is below 90/50 mmHg.
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I have a long-term skin condition from a transplant.
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I had hair loss before my cancer treatment or due to reasons not related to cancer treatment.
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I do not have scalp conditions like psoriasis that would affect hair loss assessment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Oral MinoxidilExperimental Treatment1 Intervention
Patients receive oral minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months
Group II: Placebo followed by oral MinoxidilActive Control2 Interventions
Patient receive placebo for 4 months followed by oral minoxidil for 4 months

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,299 Total Patients Enrolled
3 Trials studying Osteoporosis
237 Patients Enrolled for Osteoporosis
Mario Lacouture, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
1,985 Total Patients Enrolled
Alina Markova, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
756 Total Patients Enrolled

Media Library

Oral Minoxidil (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT05778825 — Phase 2
Osteoporosis Research Study Groups: Oral Minoxidil, Placebo followed by oral Minoxidil
Osteoporosis Clinical Trial 2023: Oral Minoxidil Highlights & Side Effects. Trial Name: NCT05778825 — Phase 2
Oral Minoxidil (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05778825 — Phase 2
~26 spots leftby Mar 2026
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