Paullinia Cupana for Anorexia in Oncologic Patients
关键词
抽象
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.
日期
| 最后验证: | 12/31/2011 |
| 首次提交: | 01/28/2012 |
| 提交的预估入学人数: | 02/21/2012 |
| 首次发布: | 02/27/2012 |
| 上次提交的更新: | 02/21/2012 |
| 最近更新发布: | 02/27/2012 |
| 实际学习开始日期: | 03/31/2011 |
| 预计主要完成日期: | 06/30/2013 |
| 预计完成日期: | 06/30/2013 |
状况或疾病
干预/治疗
Drug: Paullinea cupana
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Paullinea cupana 50mg of Paullinia cupana as capsule, twice daily | Drug: Paullinea cupana 50mg of Paullinia cupana as capsule, twice daily |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - adults (18 years old and older) - palliative care or oncologic treatment - loss of weight - anorexia Exclusion Criteria: - gastrointestinal obstruction - blood pressure not controlled - diabetes not treated |
结果
主要结果指标
1. weight [eight weeks]
次要成果指标
1. quality of life [eight weeks]
