NCT05778825

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
10mo left

Started Mar 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2023Mar 2027

First Submitted

Initial submission to the registry

March 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

March 10, 2023

Last Update Submit

February 18, 2026

Conditions

Survivors of Childhood CancerAlopecia

Keywords

Hair lossMinoxidil23-022

Outcome Measures

Primary Outcomes (2)

  • 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.

    at 4 months

  • 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.

    at 8 months

Study Arms (2)

Oral Minoxidil

EXPERIMENTAL

Patients receive oral minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months

Drug: Oral Minoxidil

Placebo followed by oral Minoxidil

ACTIVE COMPARATOR

Patient receive placebo for 4 months followed by oral minoxidil for 4 months

Drug: Oral MinoxidilOther: Placebo

Interventions

Oral MinoxidilDRUG

minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day

Oral MinoxidilPlacebo followed by oral Minoxidil
PlaceboOTHER

placebo for 4 months

Placebo followed by oral Minoxidil

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Alina Markova, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 21, 2023

Study Start

March 10, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)