Evaluation of the Effect of the Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Metastatic Colorectal Adenocarcinoma. Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Nutritional status
研究概览
简要总结
The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.
详细描述
- To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients.
- To evaluate the influence of Ocoxin®-Viusid® on tolerance to onco-specific therapy.
- Identify the changes that occur in the nutritional status of patients receiving the supplement.
- To evaluate the toxicity of Ocoxin®-Viusid® in combination with chemotherapy in patients with metastatic colorectal adenocarcinoma.
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
- •Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
- •Patients that meet the diagnostic criteria.
- •Patients with general health according to Karnofsky ≥70%.
- •Life expectancy greater than or equal to 3 months.
- •Patients eligible to receive FOLFOX-IV chemotherapy.
- •Patients who have signed the informed consent.
- •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
- •Absolute Neutrophil Count ≥1.5 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.
- •TGO and TGP 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
- •Pregnant or lactating patients.
- •Patients with known hypersensitivity to (5 Fluoracil, Folinic Acid or Oxaliplatin).
- •Patients who are receiving another product under investigation.
- •Patients with 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 puts their health at risk and his life during the study or his participation in the trial.
- •Patients with brain metastases.
- •Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
- •It is planned to include a total of 40 patients in the study, taking into account 10% of losses.
结局指标
主要结局
Nutritional status
时间窗: 8 months
Variations in the patient's nutritional status and weight at the end of treatment will be considered
Tolerance of Chemotherapy
时间窗: 8 months
Treatment with chemotherapy (CT) FOLFOX-IV will be considered
Quality of life
时间窗: 8 months
Evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) CV instruments: EORTC QLQ-C30 (general quality of life in cancer patients: Physical, Role, Emotional, Cognitive, Social, Overall quality of life, Fatigue, Nausea and vomiting, Pain valorated from 1 to 4)
次要结局
未报告次要终点