cancer of the stomach and gastric esophagus union.
Conditions
Interventions
Oncoxin-Viusid group (Experimental). Oral solution of Oncoxin-Viusid (vials of 30 ml), at a rate of 60 ml daily (1 vial every 12 hours), administrado preferably administered after breakfast and dinner
Dietary Supplements
Administration, Oral
Sponsors
Laboratorios Catalysis, SL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life. Measurement time: at baseline and, at a week after end of treatment. It will measured by: - EORTC QLQ-C30 (score of every item and global score). - EORTC EORTC QLQ-STO22 if gastric cancer (score of every item and global score). - EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score). - Karnofsky index (Score of 0-100 points at intervals of 10). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerance to Chemotherapy (It will consider the compliance to the Chemotherapy treatment in terms of time and doses plan and, it will classify in “Yes, No”). Measurement time: at each cycle of CT and, 1 week after end of treatment. 2. Nutritional status (Body Max Index calculated by Weight/(Height*Height), the weight expressed in Kg and, the height expressed in meters). Measurement time: At baseline and, 1 week after end of treatment. 3. Adverse Events-AE. Measurement time: In the two weeks prior to the QT, in the evaluation corresponding to each QT cycle and 1 week after the end of the treatment. AE will be measured as: - Type of AE (Description of the EA that is presented) - Causal Agent (QT, Oncoxin -Viusid, Other) - Seriousness of the AE (Serious, Not serious) - Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death, according to the Common Criteria of Adverse Event Terminology (CTCAE) version 4.0) - Duration of the AE (Difference between the start and end date of the event) - Causal relationship (Very likely/Definitive, Probable, Possible, Unlikely, Not related, Not assessable/Not classifiable according to the WHO classification) - Attitude towards treatment (No change, Modification of doses, Temporary interruption, Definitive interruption). 4. Results of laboratory tests (Hematological (hemoglobin, platelets, total leukocytes, CAN) and Blood chemistry (AST, ALT, total bilirubin, creatinine, glycemia, albumin, total proteins, alkaline phosphatase) .The values will be recorded according to the units established for each test, reporting as normal, abnormal, not clinically significant, abnormal clinically significant and not performed, according to the normality ranges of the institution). Measurement time: at baseline and, 1 week after end of treatment. | — |
Countries
Cuba
Contacts
Public ContactPedro Guerra Chaviano
National Coordinator Center of Clinical Trials (CENCEC)
Outcome results
None listed