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

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

Recruiting
18 years and older
Female
Phase 0

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • Patients diagnosed with Lateral epicondylitis
  • Patients with 20-50 years
  • Both males and females
  • Willing to participate and provide informed consent

Exclusion Criteria:

  • Patients with recent trauma (fractures, injury etc.)
  • Patients with blood clotting disorder (including thrombosis), oral anti-coagulants, and pacemaker, tumors at site of treatment, infected area or skin rupture or abrasion at the site of treatment, pregnancy.
  • Cervical Radiculopathy or any diseases that mimic or refer pain to elbow.
  • Patients who received steroid injection within 6 weeks.

Study details
    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

NCT05417308

Ohio State University Comprehensive Cancer Center

13 May 2026

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