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

Status: Not yet recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
Columbus
Contact Information
Primary
The Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Time Frame
Start Date: August 1, 2022
Estimated Completion Date: December 31, 2024
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov

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