RecruitingEarly Phase 1

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

United States50 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Proportion of days assigned medication was taken/applied

Timeframe: Up to 12 months

Trial details

NCT IDNCT05417308

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

The Ohio State University Comprehensive Cancer Center

800-293-5066 OSUCCCClinicaltrials@osumc.edu