Trials / Completed
CompletedNCT03549494
Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction
Effect of Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced Stomach Cancer and Esophagogastric Junction. Phase II Clinical Trial.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Catalysis SL · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
* 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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-10-25
- Primary completion
- 2022-06-15
- Completion
- 2023-02-15
- First posted
- 2018-06-08
- Last updated
- 2024-02-07
Locations
1 site across 1 country: Cuba
Source: ClinicalTrials.gov record NCT03549494. Inclusion in this directory is not an endorsement.