Clinical trial · Interventional
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.
NCT03549494CI-TRIAL-00073745completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Disease | — | UNRESOLVED | — |
| Digestive System Neoplasm | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophageal Diseases | — | UNRESOLVED | — |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophagogastric Junction Disorder | — | UNRESOLVED | — |
| Gastrointestinal Disease | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomach Diseases | — | UNRESOLVED | — |
| Stomach Neoplasm | Gastric Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ocoxin-Viusid® | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ocoxin-Viusid®
- interventionNames
- Dietary Supplement: Ocoxin-Viusid®
Primary outcomes (4)
- measure
- Quality of Life
- timeFrame
- 5 months
- description
- Karnofsky index (Score of 0-100 points at intervals of 10).
- measure
- Quality of Life
- timeFrame
- 5 months
- description
- EORTC QLQ-C30 (score of every item and global score)
- measure
- Quality of Life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: 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.
References
Publications (11)
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- BACKGROUNDPrasad KN, Hernandez C, Edwards-Prasad J, Nelson J, Borus T, Robinson WA. Modification of the effect of tamoxifen, cis-platin, DTIC, and interferon-alpha 2b on human melanoma cells in culture by a mixture of vitamins. Nutr Cancer. 1994;22(3):233-45. doi: 10.1080/01635589409514349. PMID 7877893
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- BACKGROUNDBardia A, Tleyjeh IM, Cerhan JR, Sood AK, Limburg PJ, Erwin PJ, Montori VM. Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis. Mayo Clin Proc. 2008 Jan;83(1):23-34. doi: 10.4065/83.1.23. PMID 18173999