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NCT Number: NCT05417308

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

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.

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Key information

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Brittany L. Dulmage, MD

CONTACT

[email protected]

614-565-2554

Brittany L. Dulmage, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

minoxidil

Drug

Applied topically

Other names: Alostil, Loniten, Rogaine, U 10858

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Proportion of days assigned medication was taken/applied

    Time frame: Up to 12 months

    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.

Secondary outcomes

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

    Time frame: Up to 12 months

    Adverse events will be summarized using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 with reporting of the number and percentage of patients affected. The total number of participants with AEs of any grade, and the total number of participants with grade 3 or higher AEs will be compared between randomized groups using Fisher's exact test.

  2. Change in hair density

    Time frame: Baseline to 3 months

    At least mild-to-moderate improvement in hair density from baseline to 3 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement.

  3. Change in hair density

    Time frame: Baseline to 6 months

    At least mild-to-moderate improvement in hair density from baseline to 6 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement.

  4. Change in hair density

    Time frame: Baseline to 12 months

    At least mild-to-moderate improvement in hair density from baseline to 12 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement.

  5. Chemotherapy Alopecia Distress Scale (CADS) score

    Time frame: At 3 months

    Patients will complete a a self-administered 17-item questionnaire

  6. CADS score physical

    Time frame: At 6 months

    a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical

  7. CADS score physical

    Time frame: At 6 months

    a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical relationship

  8. CADS score emotional

    Time frame: At 12 months

    a self-administered 17-item questionnaire which categorizes questions into 4 subscales including emotional relationship

  9. Patient-reported outcomes

    Time frame: At 3 months

    Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.

  10. Patient-reported outcomes

    Time frame: At 6 months

    Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.

  11. Patient-reported outcomes

    Time frame: At 12 months

    Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 14, 2022
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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