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RecruitingInterventionalEarly Phase 1

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

NCT ID: NCT05417308Sponsor: Ohio State University Comprehensive Cancer CenterLast updated: 2026-03-10

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.

Arms & interventions

  • DrugMinoxidil

    Applied topically

  • DrugMinoxidil

    Given PO

  • OtherQuality-of-Life Assessment

    Ancillary studies

  • OtherQuestionnaire Administration

    Ancillary studies

Outcome measures

Primary

  • 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

  • Occurrence of at least one adverse event (AE) of grade 1 or higher

    Time frame: Up to 12 months

  • Change in hair density

    Time frame: Baseline to 3 months

  • Change in hair density

    Time frame: Baseline to 6 months

  • Change in hair density

    Time frame: Baseline to 12 months

  • Chemotherapy Alopecia Distress Scale (CADS) score

    Time frame: At 3 months

  • CADS score physical

    Time frame: At 6 months

  • CADS score physical

    Time frame: At 6 months

  • CADS score emotional

    Time frame: At 12 months

  • Patient-reported outcomes

    Time frame: At 3 months

  • Patient-reported outcomes

    Time frame: At 6 months

  • Patient-reported outcomes

    Time frame: At 12 months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting
Brittany L. Dulmage, MD · Contact
614-565-2554brittany.dulmage@osumc.edu
Brittany L. Dulmage, MD · Principal Investigator