RPCEC00000276尚未招募2 期
Evaluation of the effect of the nutritional supplement Oncoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Phase II
Catalysis S0 个研究点目标入组 40 人开始时间: 2018年6月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
- •2. Patients that meet the diagnostic criteria.
- •3. Patients with general health according to Karnofsky =70%.
- •4. Life expectancy greater than or equal to 3 months.
- •5. Patients eligible to receive chemotherapy FOLFOX-IV scheme.
- •6. Patients who have signed the informed consent.
- •7. Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy: Hemoglobin = 90 g/l, Total Leukocyte Count = 3.0 x 109/L , Platelet Count =100 x 109/L, Total bilirubin values = 1.5 times the upper limit of the normal range established in the institution, AST and ALP values =2.5 times the upper limit of the normal interval established in the institution, Creatinine values within the normal limits of the institution.
排除标准
- •1. Patients who are receiving another onco-specific product in research.
- •2. Patients with known hypersensitivity to (5 Fluoracil, folinic acid or oxaliplatin).
- •3. Decompensated intercurrent diseases, including hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that, at the discretion of the doctor, endangers their health and his life during the study or his participation in the trial.
- •4. Pregnant or lactating women.
- •5. Patients with mental disorders that could limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
- •6. Patients with cerebral metastases.
研究者
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