Guarana (Paullinia Cupana) for Anorexia Related to Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- weight
研究概览
简要总结
Denutrition, lost of weight and anorexia are present in many oncologic patients at any time of the disease. Anorexia is the spontaneous loss of appetite and many changes in the metabolism are made in this case, leading to this syndrome called anorexia-cachexia, that includes changes in the tumoral response and inflammatory pathways. The guaraná (Paullinia cupana) is originally from Brazil and Venezuela and has been used culturally for headaches, muscle pains, depression and others. As it has shown a good response and tolerability for fatigue, the investigators decide to try guaraná for anorexia. Patients will receive guaraná as capsules of 50 mg twice daily, for 4 weeks, and will be weighted and respond questionaries about quality of life.
详细描述
Patients 18 years and older, diagnosed with any cancer, that is losing weight and have anorexia will be selected. They must have normal levels of creatinine, thyroid evaluation and hepatic function. If they are taking corticosteroid, they must keep losing weight and refer anorexia, as well as if they are on treatment with chemotherapy.
Patients will receive 50mg of the guaraná twice daily for 4 weeks. Every week will be an evaluation of the weight, level of appetite and answer 2 questionaries of quality of life and level of symptoms (FACT-G and MDASI).
This is a fase II study, open-label, no randomized, with two steps following ¨two stages of Simon¨ model. First step 18 patients will be included and if there are 3 good responses second step will follow, including 17 more patients. Response will be considered if there is at least 5% of gain in the weight.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (18 years old and older)
- •palliative care or oncologic treatment
- •loss of weight
排除标准
- •gastrointestinal obstruction
- •blood pressure not controlled
- •diabetes not treated
研究组 & 干预措施
Paullinea cupana
50mg of Paullinia cupana as capsule, twice daily
干预措施: Paullinia cupana (Drug)
结局指标
主要结局
weight
时间窗: eight weeks
Patients will considered to respond to guaraná if the gain 5% or more of his inicial weight during the treatment period
次要结局
- quality of life(eight weeks)
研究者
Felipe Melo Cruz
MsC
Faculdade de Medicina do ABC