Status:
RECRUITING
Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
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 ca...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of low-dose oral minoxidil in patients with breast cancer and EIA. II. To obtain preliminary data to support whether low-dose oral mino...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05417308
Start Date
March 1 2023
End Date
December 31 2025
Last Update
April 4 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210