A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of days assigned medication was taken/applied
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (topical minoxidil)
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.
干预措施: Minoxidil (Drug)
Arm I (topical minoxidil)
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.
干预措施: Quality-of-Life Assessment (Other)
Arm I (topical minoxidil)
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.
干预措施: Questionnaire Administration (Other)
Arm II (orally minoxidil)
Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
干预措施: Minoxidil (Drug)
Arm II (orally minoxidil)
Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm II (orally minoxidil)
Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Proportion of days assigned medication was taken/applied
时间窗: 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.
次要结局
- Occurrence of at least one adverse event (AE) of grade 1 or higher(Up to 12 months)
- Patient-reported outcomes(At 12 months)
- Change in hair density(Baseline to 12 months)
- Chemotherapy Alopecia Distress Scale (CADS) score(At 3 months)
- CADS score emotional(At 12 months)
- CADS score physical(At 6 months)
- Change in hair density(Baseline to 3 months)
- Change in hair density(Baseline to 6 months)
- Patient-reported outcomes(At 3 months)
- Patient-reported outcomes(At 6 months)
研究者
Brittany Dulmage
Principal Investigator
Ohio State University Comprehensive Cancer Center