NCT04459650已完成早期 1 期
A Pilot Study of the Clinical Effectiveness of Platelet-Rich Plasma (PRP) for the Treatment of Endocrine Therapy-Induced Alopecia (EIA) and Permanent Chemotherapy-Induced Alopecia (pCIA) in Breast Cancer Patients
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Hair Density
研究概览
简要总结
Participants who enroll in this study will undergo the platelet-rich plasma (PRP) study treatment. Participants will have a sample of blood collected and the platelets will be separated and then injected into half of the participants' scalp every 4 weeks for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women ≥ 18 years of age
- •Have a clinical diagnosis of endocrine therapy induced alopecia (EIA) for breast cancer:
- •Selective estrogen receptor modulators (tamoxifen, toremifene)
- •Aromatase inhibitors (anastrozole, letrozole, exemestane)
- •Gonadotropin-releasing hormone agonist (leuprolide)
- •Must have a clinical diagnosis of chemotherapy induced (pCIA) alopecia with incomplete or absent regrowth of hair > 3 months after completion of chemotherapy without use of endocrine cancer-related therapy (ET) within the last 6 months
- •Ludwig stage 1-3 for women
- •If patient has a history of use of topical minoxidil and/or systemic spironolactone for alopecia for at least three consecutive months, then a 3 month washout is required prior to start of treatment
- •Completed informed consent form
排除标准
- •Patients who are pregnant or breastfeeding
- •History of hair transplantation
- •Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2weeks prior to screening. Note: patients are not permitted to use any hair loss products during the study.
- •An active scalp dermatologic condition (e.g. alopecia areata, scalp psoriasis), scalp skin cancer (e.g. BCC, SCC), a pre-existing condition with sequelae on the scalp (e.g. scarring alopecia) or acute infection.
- •Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia (platelet count <150,000 platelets/ul),hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia).
- •Actively receiving anticoagulant medication
- •Patients taking Aspirin or other NSAIDs such as Nurofen, Voltaren, Diclofenac or Naproxen, or fish-oil supplements because of its anti-platelet activity, can participate, provided medication is interrupted 7 days before beginning of the treatment.
- •Planned or previous radiation therapy to the brain
- •Vulnerable populations e.g. decisionally impaired (cognitive, psychiatric) or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
- •Patients taking hair supplements, such as biotin or biosil, can participate, provided hair supplements are washed out 3 months prior to beginning of treatment.
结局指标
主要结局
Hair Density
时间窗: 12 weeks from baseline
The primary endpoint of this study is the is the relative density in scalp hair at week 12compared to baseline (week 0) between treatment and observation sides of the scalp. The study investigator will use the 7-point GAS (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, and +3 = greatly increased) to evaluate relative differences in hair density.
次要结局
未报告次要终点
研究者
研究点 (2)
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