Recruiting
Early Phase 1

Minoxidil

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT05417308

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage IA Breast Cancer AJCC v8

Anatomic Stage IB Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage IIA Breast Cancer AJCC v8

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Minoxidil

Minoxidil

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage IA Breast Cancer AJCC v8

Anatomic Stage IB Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage IIA Breast Cancer AJCC v8

Study ID

NCT05417308

Start date

Mar 1, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (topical 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.

experimental: Arm II (orally minoxidil)

Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.

Interventions

Minoxidil

Applied topically

Minoxidil

Given PO

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Proportion of days assigned medication was taken/applied [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Brittany L. Dulmage, MD

614-565-2554brittany.dulmage@osumc.edu

Principal Investigator:

Brittany L. Dulmage, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-03-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.