Trials / Recruiting

RecruitingNCT05417308

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

A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients

Status: Recruiting
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 50 (estimated)

Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DRUG	Minoxidil	Applied topically
DRUG	Minoxidil	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2023-03-01
Primary completion: 2027-12-01
Completion: 2027-12-31
First posted: 2022-06-14
Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05417308. Inclusion in this directory is not an endorsement.