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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-01932 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This early phase I trial studies the possible benefits and/or side effects of topical or oral minoxidil in treating endocrine therapy-induced hair loss (alopecia) in patients with stage I-IV breast cancer. Endocrine therapy-induced alopecia (EIA) is a distressing side effect that leads to reduced quality of life and early cessation of therapy in women undergoing treatment for breast cancer. Patients on endocrine therapy commonly report hair loss or thinning. Minoxidil is a drug that may promote hair growth and reduce hair loss. Oral minoxidil may increase hair density in women with EIA, and work the same as topical minoxidil in treating EIA in patients with breast cancer.
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of low-dose oral minoxidil in patients with breast cancer and EIA.
II. To obtain preliminary data to support whether low-dose oral minoxidil is a reasonable alternative to topical minoxidil in patients with EIA.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients apply minoxidil foam topically to affected areas of the scalp once daily (QD) for up to 12 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive minoxidil orally (PO) QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (topical minoxidil) | Active Comparator | Patients apply minoxidil foam topically to affected areas of the scalp QD for up to 12 months in the absence of disease progression or unacceptable toxicity. |
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| Arm II (orally minoxidil) | Experimental | Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minoxidil | Drug | Applied topically |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of days assigned medication was taken/applied | For the oral minoxidil group, the proportion of pills taken will be reported with a 95% confidence interval. For the topical minoxidil group, the proportions of days medication was applied will be reported with a 95% confidence interval. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of at least one adverse event (AE) of grade 1 or higher | Adverse events will be summarized using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 with reporting of the number and percentage of patients affected. The total number of participants with AEs of any grade, and the total number of participants with grade 3 or higher AEs will be compared between randomized groups using Fisher's exact test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brittany L Dulmage, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Minoxidil | Drug | Given PO |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 12 months |
| Change in hair density | At least mild-to-moderate improvement in hair density from baseline to 3 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement. | Baseline to 3 months |
| Change in hair density | At least mild-to-moderate improvement in hair density from baseline to 6 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement. | Baseline to 6 months |
| Change in hair density | At least mild-to-moderate improvement in hair density from baseline to 12 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement. | Baseline to 12 months |
| Chemotherapy Alopecia Distress Scale (CADS) score | Patients will complete a a self-administered 17-item questionnaire | At 3 months |
| CADS score physical | a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical | At 6 months |
| CADS score physical | a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical relationship | At 6 months |
| CADS score emotional | a self-administered 17-item questionnaire which categorizes questions into 4 subscales including emotional relationship | At 12 months |
| Patient-reported outcomes | Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test. | At 3 months |
| Patient-reported outcomes | Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test. | At 6 months |
| Patient-reported outcomes | Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test. | At 12 months |
| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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