Clinical trial · Interventional
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
Efficacy of the Oncoxin-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced or Metastatic Ovarian Epithelial Cancer. Clinical Trial Phase II.
NCT03562897CI-TRIAL-00059513completedPhase 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 hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adnexal Diseases | — | UNRESOLVED | — |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endocrine Gland Neoplasm | — | UNRESOLVED | — |
| Endocrine System Diseases | — | UNRESOLVED | — |
| Female Urogenital Diseases | — | UNRESOLVED | — |
| Female Urogenital Diseases and Pregnancy Complications | — | UNRESOLVED | — |
| Genital Diseases, Female | — | UNRESOLVED | — |
| Genital Neoplasm, Female | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Gonadal Disorders | — | UNRESOLVED | — |
| Neoplasms, Glandular and Epithelial | Neoplasm | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ocoxin-Viusid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ocoxin-Viusid®
- description
- Ocoxin-Viusid® before, during and after the Chemotherapy treatment.
- interventionNames
- Dietary Supplement: Ocoxin-Viusid
Primary outcomes (3)
- measure
- Quality of life
- timeFrame
- 4 months
- description
- It will measured by: - EORTC QLQ-C30 (Points of every item and final points)
- measure
- Quality of life
- timeFrame
- 4 months
- description
- Karnofsky index (Score of 0-100 points at intervals of 10)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients 18 years of age or older. 2. Patients with diagnosis of ovarian epithelial cancer in stages III (not resectable) and IV. 3. Patients with general health status according to the Karnofsky Index ≥ 70 (Annex 12). 4. Life expectancy equal to or greater than 3 months. 5. Patients who give their informed consent in writing to participate in the study. 6. Normal functioning of organs and bone marrow defined by the following parameters: -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 -Glycemia values ≤ 10 Umol / L -Values of Creatinine and total bilirubin within the normal limits of the institution. -Values of AST / ALT ≤2.5 times the upper limit of the normal interval established in the institution. 7. Patients with a history of cardiovascular disease, with ejection fraction ≥ 55%, measured by echocardiogram. Exclusion Criteria: 1. Patients who are receiving another research product. 2. Patients with known hypersensitivity to QT with Carboplatin, Cisplatin and / or Paclitaxel. 3. Patients in stage III tributary of surgical treatment at diagnosis. 4. Patients with known hypersensitivity to any ingredient of the product research. 5. Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver diseases and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health or life at risk during your participation in the trial. 6. Pregnancy, breastfeeding or puerperium. 7. Patients with brain metastases and/or leptomeningeal carcinosis. 8. Patients' carrier of the human immunodeficiency virus (HIV).
References
Publications (14)
- BACKGROUNDPrat J. New insights into ovarian cancer pathology. Ann Oncol. 2012 Sep;23 Suppl 10:x111-7. doi: 10.1093/annonc/mds300. PMID 22987944
- BACKGROUNDJelovac D, Armstrong DK. Recent progress in the diagnosis and treatment of ovarian cancer. CA Cancer J Clin. 2011 May-Jun;61(3):183-203. doi: 10.3322/caac.20113. Epub 2011 Apr 26. PMID 21521830
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5. PMID 25559415
- BACKGROUNDLanden CN Jr, Birrer MJ, Sood AK. Early events in the pathogenesis of epithelial ovarian cancer. J Clin Oncol. 2008 Feb 20;26(6):995-1005. doi: 10.1200/JCO.2006.07.9970. Epub 2008 Jan 14. PMID 18195328
- BACKGROUNDFuchs-Tarlovsky V, Alvarez-Altamirano K, Turquie-Sacal D, Alvarez-Flores C, Hernandez-Steller H. Nutritional status and body composition are already affected before oncology treatment in ovarian cancer. Asia Pac J Clin Nutr. 2013;22(3):426-30. doi: 10.6133/apjcn.2013.22.3.12. PMID 23945413
- BACKGROUNDGupta D, Lis CG, Vashi PG, Lammersfeld CA. Impact of improved nutritional status on survival in ovarian cancer. Support Care Cancer. 2010 Mar;18(3):373-81. doi: 10.1007/s00520-009-0670-y. Epub 2009 May 31. PMID 19484479
- BACKGROUNDKathiresan AS, Brookfield KF, Schuman SI, Lucci JA 3rd. Malnutrition as a predictor of poor postoperative outcomes in gynecologic cancer patients. Arch Gynecol Obstet. 2011 Aug;284(2):445-51. doi: 10.1007/s00404-010-1659-y. Epub 2010 Aug 29. PMID 20803205
- BACKGROUNDMadhok BM, Yeluri S, Haigh K, Burton A, Broadhead T, Jayne DG. Parenteral nutrition for patients with advanced ovarian malignancy. J Hum Nutr Diet. 2011 Apr;24(2):187-91. doi: 10.1111/j.1365-277X.2010.01127.x.