Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03549494|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasm Gastrointestinal Neoplasms Digestive System Neoplasm Esophageal Neoplasms Head and Neck Neoplasms Gastrointestinal Disease Digestive System Disease Esophageal Diseases Stomach Diseases Esophagogastric Junction Disorder||Dietary Supplement: Ocoxin-Viusid®||Phase 2|
- 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 (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced Stomach Cancer and Esophagogastric Junction. Phase II Clinical Trial.|
|Actual Study Start Date :||October 25, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
Dietary Supplement: Ocoxin-Viusid®
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
- Quality of Life [ Time Frame: 5 months ]Karnofsky index (Score of 0-100 points at intervals of 10).
- Quality of Life [ Time Frame: 5 months ]EORTC QLQ-C30 (score of every item and global score)
- Quality of Life [ Time Frame: 5 months ]EORTC QLQ-STO22 if gastric cancer (score of every item and global score)
- Quality of Life [ Time Frame: 5 months ]EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score)
- Nutritional Status [ Time Frame: 5 months ]Body mass Index calculated by Weight/(Height*Height), the weight expressed in Kg and, the height expressed in meters.
- Chemotherapy Tolerance [ Time Frame: 5 months ]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").
- Adverse Events-AE [ Time Frame: 5 months ]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)
- Results of laboratory tests [ Time Frame: 5 months ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549494
|Contact: Pedro P. Guerra Chaviano, Mscemail@example.com|
|National Institute of Oncology and Radiobiology (INOR)||Recruiting|
|Havana, La Habana, Cuba, 10400|
|Contact: Luis E. Alsina Tul, Dr. +53-78388589 firstname.lastname@example.org|
|Principal Investigator: Luis E. Alsina Tul, Dr.|
|Sub-Investigator: Yanelys Mir Espinosa, Dr.|
|Sub-Investigator: Giselle Álvarez Pérez, BSc|
|Sub-Investigator: Karelia Silvera Candó, BSc|
|Sub-Investigator: Zaida Lastre Sosa, BSc|
|Sub-Investigator: Janet Lamadrid García, Dr.|
|Sub-Investigator: Danay Corrales Otero, Dr.|
|Sub-Investigator: Marta Lugioyo Lugo, BSc|
|Sub-Investigator: Juan J. Lence Anta, Dr.|