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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Minoxidil | Experimental | Patients receive oral minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months |
|
| Placebo followed by oral Minoxidil | Active Comparator | Patient receive placebo for 4 months followed by oral minoxidil for 4 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Minoxidil | Drug | minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alina Markova, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| Placebo | Other | placebo for 4 months |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |