NCT03549494已完成2 期
Effect of Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced Stomach Cancer and Esophagogastric Junction. Phase II Clinical Trial.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
Our main objective is to evaluate the effect of Ocoxin-Viusid on the quality of life of patients with advanced stomach cancer and esophagogastric junction. The Ocoxin-Viusid nutritional supplement is expected to improve quality of life and tolerance to treatment with Chemotherapy.
详细描述
- To evaluate the effect of Ocoxin-Viusid on the quality of life of patients
- To evaluate the toxicity of Ocoxin-Viusid in combination with chemotherapy (QT).
- To assess the influence of Ocoxin-Viusid on tolerance to treatment with chemotherapy.
- Identify the changes that occur in the nutritional status of patients receiving the supplement.
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 with cyto-histological diagnosis of stomach adenocarcinoma and gastric esophageal junction in stages III and IV, which are tributaries of the FOLFOX chemotherapy scheme.
- •Patients of any sex with age ≥ 18 years.
- •Patients with clinical status according to Karnofsky index ≥ 70%.
- •Patients with life expectancy ≥ 3 months.
- •Clinically fit patients to receive the FOLFOX chemotherapy scheme.
- •Patients who have signed informed consent for the investigation.
- •Patients with laboratory parameters within normal limits 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 ≤ 1.5 times the upper limit of the normal range established in the institution, TGO / TGP ≤2.5 times the upper limit of the normal range established in the institution, creatinine within the limits normal of the institution.
- •Patients of childbearing age with negative pregnancy test and use appropriate contraceptive methods such as intrauterine devices, barrier or tubal ligation methods, hormonal contraceptives. In the case of male sex (vasectomy, use of condoms) while the treatment lasts.
排除标准
- •Patients with stomach cancer and gastric esophageal junction in stages III and IV, tributaries of surgical treatment and / or radiotherapy.
- •Patients who are being treated with another product under investigation.
- •Patients with known hypersensitivity to any component of the investigational product.
- •Patients with known hypersensitivity to any component of the Chemotherapy (FOLFOX).
- •Patients with acute allergic states or history of severe allergic reactions.
- •Patients with acute, chronic, or inflammatory decompensated infectious diseases.
- •Patients with brain metastases.
- •Patients with psychiatric disorders that make it difficult to collect information, treatment or follow-up.
- •Patients in the period of breast-feeding or puerperium.
结局指标
主要结局
Quality of Life
时间窗: 5 months
Karnofsky index (Score of 0-100 points at intervals of 10).
次要结局
- Adverse Events-AE(5 months)
- Results of laboratory tests(5 months)
- Nutritional Status(5 months)
- Chemotherapy Tolerance(5 months)
研究者
研究点 (2)
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