A Pilot Study of Oral Minoxidil for the Treatment of Persistent Hair Loss in Pediatric, Adolescent, and Young Adult Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
研究概览
简要总结
This study will test whether minoxidil taken by mouth (oral minoxidil) can improve hair loss caused by cancer treatment in children and young adults. In addition, the researchers will test the safety of oral minoxidil, and see if the study drug causes few or mild side effects in participants. Other purposes of this study include looking at whether participants are able to follow their study drug dosing schedules, and how oral minoxidil affects participants' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have been diagnosed with cancer before the age of
- •They must have completed either systemic or radiation therapy (cytotoxic chemotherapy and external beam radiation therapy) for their cancer at least 1 year prior to study entry.
- •They must be between 6-18 years old at the time of enrollment.
- •They must have a clinical diagnosis of persistent or late alopecia for >6 months and that is definitely, probably, or possibly related to prior chemotherapy and/or radiation.
排除标准
- •Had a history of alopecia prior to systemic or radiation therapy for cancer, or has alopecia unrelated to cancer treatment.
- •Have scalp disorders that preclude the evaluation of alopecia, such as psoriasis
- •Has a known hypersensitivity to minoxidil
- •Concurrent use of other therapies for alopecia
- •Concurrent active anticancer therapies (cytotoxic, targeted, endocrine, immunologic)
- •History of chronic sclerotic cutaneous GvHD affecting the scalp
- •Active chronic cutaneous GvHD
- •History of orthostatic or symptomatic hypotension, syncope related to hypotension; systolic less than or equal than 100 (for adults) and 90 (for children) at screening.
- •Pregnancy.
- •Cardiovascular disease that in the opinion of the cardiologist makes the patient unsuitable for therapy
- •Blood pressure less than the 5th percentile or less than 90/50 mmHg for children 10 years or older
研究组 & 干预措施
Oral Minoxidil
Patients receive oral minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months
干预措施: Oral Minoxidil (Drug)
Placebo followed by oral Minoxidil
Patient receive placebo for 4 months followed by oral minoxidil for 4 months
干预措施: Oral Minoxidil (Drug)
Placebo followed by oral Minoxidil
Patient receive placebo for 4 months followed by oral minoxidil for 4 months
干预措施: Placebo (Other)
结局指标
主要结局
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
时间窗: at 8 months
as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements.
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
时间窗: at 4 months
as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements.
次要结局
未报告次要终点