Using minoxidil to treat hair loss in breast cancer patients on endocrine therapy
A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05417308 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.