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.
* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
45
Ocoxin-Viusid group (Experimental). Oral solution of Ocoxin-Viusid (vials of 30 ml), at a rate of 60 ml daily (1 vial every 12 hours), administrado preferably administered after breakfast and dinner. The product will dilute in water, milk or juice. The treatment will have a period of 19 weeks, starting 2 weeks before the onco-specific treatment with FOLFOX chemotherapy and will end 3 weeks after the end of the sixth cycle of chemotherapy. QT FOLFOX will be prescribed intravenously every 14 days for 6 cycles as follows: Oxaliplatin (85 mg x m2) on day 1 Folinic acid (200 mg x m2) on day 1 and 2 5 Fluoracil (400 mg x m2, bolus) on day 1 and 2 5 Fluoracil (600 mg x m2, continuous infusion) on day 1 and 2
National Institute of Oncology and Radiobiology (INOR)
Havana, La Habana, Cuba
Quality of Life
Karnofsky index (Score of 0-100 points at intervals of 10).
Time frame: 5 months
Quality of Life
EORTC QLQ-C30 (score of every item and global score)
Time frame: 5 months
Quality of Life
EORTC QLQ-STO22 if gastric cancer (score of every item and global score)
Time frame: 5 months
Quality of Life
EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score)
Time frame: 5 months
Nutritional Status
Body mass Index calculated by Weight/(Height\*Height), the weight expressed in Kg and, the height expressed in meters.
Time frame: 5 months
Chemotherapy Tolerance
Adverse Reactions (It will consider the compliance to the Chemotherapy treatment in terms of time and doses plan and, it will classify in "Yes, No").
Time frame: 5 months
Adverse Events-AE
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)
Time frame: 5 months
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)
Time frame: 5 months
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