CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Ocoxin-Viusid®dietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03549494
NCT03549494Phase 2Completed

Effect of Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced Stomach Cancer and Esophagogastric Junction. Phase II Clinical Trial.

Catalysis SL·interventional·Posted Jun 8, 2018·Updated Feb 7, 2024

In Brief

A Phase 2 clinical trial evaluating Ocoxin-Viusid® for Stomach Neoplasm and 9 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 8, 2018
Enrollment StartOct 25, 2018
Primary CompletionJun 15, 2022
Study CompletionFeb 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.1 years ago

Interventions

Ocoxin-Viusid®dietary

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