Back to resultsA Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors
Primary Purpose
Survivors of Childhood Cancer, Alopecia
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral Minoxidil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Survivors of Childhood Cancer focused on measuring Hair loss, Minoxidil, 23-022
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 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
Sites / Locations
- Memorial Sloan Kettering Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oral Minoxidil
Placebo followed by oral Minoxidil
Arm Description
Patients receive oral minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months
Patient receive placebo for 4 months followed by oral minoxidil for 4 months
Outcomes
Primary Outcome Measures
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
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.
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05778825
First Posted
March 10, 2023
Last Updated
October 19, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05778825
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Survivors of Childhood Cancer, Alopecia
Keywords
Hair loss, Minoxidil, 23-022
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Minoxidil
Arm Type
Experimental
Arm Description
Patients receive oral minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months
Arm Title
Placebo followed by oral Minoxidil
Arm Type
Active Comparator
Arm Description
Patient receive placebo for 4 months followed by oral minoxidil for 4 months
Intervention Type
Drug
Intervention Name(s)
Oral Minoxidil
Intervention Description
minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo for 4 months
Primary Outcome Measure Information:
Title
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
Description
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.
Time Frame
at 4 months
Title
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
Description
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.
Time Frame
at 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Lacouture, MD
Phone
646-361-6536
Email
lacoutum@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Friedman, MD
Phone
212-639-7376
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Lacouture, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Lacouture, MD
Phone
646-361-6536
First Name & Middle Initial & Last Name & Degree
Danielle Friedman, MD
Phone
212-639-7376
First Name & Middle Initial & Last Name & Degree
Mario Lacouture, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors
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