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

NCT05417308 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-20340NCI-2021-01932
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA 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; 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

Outcome Measures

Primary Outcomes (1)

• Proportion of days assigned medication was taken/applied

  For the oral minoxidil group, the proportion of pills taken will be reported with a 95% confidence interval. For the topical minoxidil group, the proportions of days medication was applied will be reported with a 95% confidence interval.

  Up to 12 months

Secondary Outcomes (11)

• Occurrence of at least one adverse event (AE) of grade 1 or higher

  Up to 12 months

• Change in hair density

  Baseline to 3 months

• Change in hair density

  Baseline to 6 months

• Change in hair density

  Baseline to 12 months

• Chemotherapy Alopecia Distress Scale (CADS) score

  At 3 months

Study Arms (2)

Arm I (topical minoxidil)

ACTIVE COMPARATOR

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.

Drug: Minoxidil; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (orally minoxidil)

EXPERIMENTAL

Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.

Drug: Minoxidil; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Minoxidil DRUG

Applied topically

Also known as: Alostil, Loniten, Rogaine, U 10858

Arm I (topical minoxidil)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (topical minoxidil); Arm II (orally minoxidil)

Questionnaire Administration OTHER

Ancillary studies

Arm I (topical minoxidil); Arm II (orally minoxidil)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Interventions

Minoxidil

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Brittany L Dulmage, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: June 14, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)