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

Early Phase 1

Recruiting

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Endocrine Therapy-Induced Alopecia; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8
• Interventions: Drug: Minoxidil; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT05417308
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-14
• Study Start: 2023-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Prior or ongoing use of spironolactone
• Known sensitivity to minoxidil
• Untreated hypothyroidism or iron deficiency as determined by thyroid stimulating hormone (TSH) with reflex free T4 and ferritin level > 40 to be checked at the time of enrolling if not completed in the 12 months prior

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (orally minoxidil)	Quality-of-Life Assessment	Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
Arm II (orally minoxidil)	Questionnaire Administration	Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
Arm I (topical minoxidil)	Questionnaire Administration	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.
Arm I (topical minoxidil)	Quality-of-Life Assessment	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.
Arm II (orally minoxidil)	Minoxidil	Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
Arm I (topical minoxidil)	Minoxidil	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.

Primary Outcome Measures

Name	Time	Method
Proportion of days assigned medication was taken/applied	Up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Occurrence of at least one adverse event (AE) of grade 1 or higher	Up to 12 months	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.
Patient-reported outcomes	At 12 months	Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.
Change in hair density	Baseline to 12 months	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.
Chemotherapy Alopecia Distress Scale (CADS) score	At 3 months	Patients will complete a a self-administered 17-item questionnaire
CADS score physical	At 6 months	a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical relationship
CADS score emotional	At 12 months	a self-administered 17-item questionnaire which categorizes questions into 4 subscales including emotional relationship

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States