Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer
Purpose
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.
Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Endocrine Therapy-Induced Alopecia
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage IV Breast Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Columbus, Ohio 43210
More Details
- NCT ID
- NCT05417308
- Status
- Recruiting
- Sponsor
- Ohio State University Comprehensive Cancer Center
Study Contact
The Ohio State University Comprehensive Cancer Center800-293-5066
OSUCCCClinicaltrials@osumc.edu
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 minoxidil is a reasonable alternative to topical minoxidil in patients with EIA. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients apply minoxidil foam topically to affected areas of the scalp once daily (QD) for up to 12 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive minoxidil orally (PO) QD for up to 12 months in the absence of disease progression or unacceptable toxicity.