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NCT05417308 | RECRUITING | Anatomic Stage I Breast Cancer AJCC v8

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

Ohio State University Comprehensive Cancer Center

Information provided by (Responsible Party):

Brittany Dulmage

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 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.

Condition or disease

Anatomic Stage I Breast Cancer AJCC v8

Anatomical 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

Intervention/treatment

Minoxidil

Minoxidil

Quality-of-Life Assessment

Questionnaire Administration

Phase

EARLY_PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients
Actual Study Start Date : 2023-03-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer

Location Details

NCT05417308

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Locations

RECRUITING

United States, Ohio

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210