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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Minoxidil
  Applied topically
• Препарат Minoxidil
  Given PO
• Другое Quality-of-Life Assessment
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Proportion of days assigned medication was taken/applied [Срок оценки: Up to 12 months]

Вторичные конечные точки (11)

• Occurrence of at least one adverse event (AE) of grade 1 or higher [Срок оценки: Up to 12 months]
• Change in hair density [Срок оценки: Baseline to 3 months]
• Change in hair density [Срок оценки: Baseline to 6 months]
• Change in hair density [Срок оценки: Baseline to 12 months]
• Chemotherapy Alopecia Distress Scale (CADS) score [Срок оценки: At 3 months]
• CADS score physical [Срок оценки: At 6 months]
• CADS score physical [Срок оценки: At 6 months]
• CADS score emotional [Срок оценки: At 12 months]
• Patient-reported outcomes [Срок оценки: At 3 months]
• Patient-reported outcomes [Срок оценки: At 6 months]
• Patient-reported outcomes [Срок оценки: At 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Ohio State University Comprehensive Cancer Center — Columbus

Идентификаторы

NCT: NCT05417308 · OSU-20340 · NCI-2021-01932

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗