Using minoxidil to treat hair loss in breast cancer patients on endocrine therapy
Official title: A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients
Run by Ohio State University Comprehensive Cancer Center · NCT05417308 · Data updated 2026-11-12
This study is testing if a hair loss treatment called minoxidil, given either as a foam or a pill, can help women with breast cancer who are losing their hair due to cancer therapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | December 1, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT05417308 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with a diagnosis of breast cancer stages I-IV who are currently on endocrine therapy and experiencing hair loss.
✕Probably not a fit
Patients who are pregnant, nursing, or have a history of certain types of alopecia or prior use of minoxidil may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early phase I trial investigates the effects of topical and oral minoxidil on hair loss caused by endocrine therapy in women with stage I-IV breast cancer. The study aims to evaluate the safety and tolerability of low-dose oral minoxidil and to gather preliminary data on its effectiveness compared to topical minoxidil. Participants will be randomized into two groups: one applying minoxidil foam topically and the other receiving it orally, both for up to 12 months. The trial focuses on improving quality of life by addressing the distressing side effect of hair loss during cancer treatment.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for hair loss in breast cancer patients undergoing endocrine therapy, potentially improving their quality of life.
How similar studies have gone: While the use of minoxidil for hair loss is established, this specific application in breast cancer patients undergoing endocrine therapy is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Brittany L Dulmage, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.