Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- assessment of benefits on quality of life after treatment during two months
研究概览
简要总结
Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. Patients and methods: This prospective phase II study will assess the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on individuals with advanced solid tumors, with no further therapeutic options and with at least 2 months life expectancy. In addition, several biochemical and inflammatory parameters will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals with advanced solid tumors, with no further therapeutic options and with at least 2 moths life expectancy
- •individuals 18 years of age and older
- •creatinine levels up to twice the upper limit of normal (ULN)
- •alanine (ALT) and aspartate (ASP) transaminase levels up to twice the ULN and direct bilirubin (DB) levels up to 1.5 times the ULN
- •in cases with pre-existing liver disease, the ALT, ASP and DB levels could be up to 2.5 times the ULN
排除标准
- •pregnant and breastfeeding women
- •individuals using chemotherapy or other tumor-targeting antineoplastic treatments, except for antalgic radiotherapy
- •severe kidney or liver failure
- •known hypersensitiveness to the components of the medication used
- •past history of emotional disorders that could interfere with the data collection.
研究组 & 干预措施
cat's claw
100 mg dose of a dry extract of U. tomentosa three times per day
干预措施: uncaria tomentosa (cat´s claw) (Drug)
结局指标
主要结局
assessment of benefits on quality of life after treatment during two months
时间窗: two months
Assess the efficacy and safety of a dry extract of U. tomentosa on individuals who had solid tumors with no further therapeutic options
次要结局
未报告次要终点
研究者
Felipe Melo Cruz
MsC
Faculdade de Medicina do ABC