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

Last updated: April 2, 2025
Sponsor: Ohio State University Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

1

Condition

Hair Loss

Alopecia

Treatment

Minoxidil

Quality-of-Life Assessment

Questionnaire Administration

Clinical Study ID

NCT05417308
OSU-20340
NCI-2021-01932
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 withoutconcurrent use of ovarian function suppression

  • Self-reporting hair loss since starting endocrine therapy

Exclusion

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 stimulatinghormone (TSH) with reflex free T4 and ferritin level > 40 to be checked at the timeof enrolling if not completed in the 12 months prior

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: Minoxidil
Phase: 1
Study Start date:
March 01, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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