Effect of the nutritional supplement Oncoxin-Viusid in the quality of life of patients with advanced cancer of the stomach and gastric esophagus union.

aboratorios Catalysis, S0 个研究点目标入组 45 人开始时间: 2018年5月10日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1. 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.
•2. Patients of any sex with age = 18 years.
•3. Patients with clinical status according to Karnofsky index = 70%.
•4. Patients with life expectancy = 3 months.
•5. Clinically fit patients to receive the FOLFOX chemotherapy scheme.
•6. Patients who have signed informed consent for the investigation.
•7. 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.
•8. 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.

•1. Patients with stomach cancer and gastric esophageal junction in stages III and IV, tributaries of surgical treatment and / or radiotherapy.
•2. Patients who are being treated with another product under investigation.
•3. Patients with known hypersensitivity to any component of the investigational product.
•4. Patients with known hypersensitivity to any component of the Chemotherapy (FOLFOX).
•5. Patients with acute allergic states or history of severe allergic reactions.
•6. Patients with acute, chronic, or inflammatory decompensated infectious diseases.
•7. Patients with brain metastases.
•8. Patients with psychiatric disorders that make it difficult to collect information, treatment or follow-up.
•9. Patients in the period of breast-feeding or puerperium.

发起方

aboratorios Catalysis, S