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Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer

ConditionsAnatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Endocrine Therapy-Induced AlopeciaPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women >= 18 years of age

Established diagnosis of breast cancer stages I-IV

On endocrine therapy including tamoxifen or aromatase inhibitors with or without concurrent use of ovarian function suppression

Self-reporting hair loss since starting endocrine therapy

Disqualifiers

Pregnant or nursing women

Current chemotherapy use or prior chemotherapy use within the last 2 years

History of scarring/cicatricial alopecia or alopecia areata

Prior use of oral or topical minoxidil

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minoxidil

    Drug

    Applied topically

  • Minoxidil

    Drug

    Given PO

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm I (topical minoxidil)Active comparator 3 interventions
Group B: Arm II (orally minoxidil)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 12 months

Secondary outcomes

1

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.

Time frame
Up to 12 months
2

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.

Time frame
Baseline to 3 months
3

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.

Time frame
Baseline to 6 months
4

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.

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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