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RecruitingEarly Phase 1NCT05417308

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

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

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

50 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8Endocrine Therapy-Induced Alopecia

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

Interventions

DRUGMinoxidil

Applied topically

DRUGMinoxidil

Given PO

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT05417308

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