Epithelial advanced or metastatic ovarian cancer
Conditions
Interventions
Oncoxin-Viusid group (Experimental): Oral solution Oncoxin-Viusid (30 ml vials) were used at a rate of 60ml / day (1 vial every 12 hours), preferably administered after breakfast and dinner. The treat
Dietary Supplements
Administration, Oral
Oncoxin viusid,
Oral Solution
Sponsors
Catalysis Laboratory S.L.
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life. It will measured by: - EORTC QLQ-C30 (Points of every item and final points). Measurement time: at baseline and, 3 weeks after finished the third CT cycle - EORTC QLQ-OV28 (Points of every item and final points). Measurement time: at baseline and, 3 weeks after finished the third CT cycle - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at baseline, in every CT cycle and, 3 weeks after the third CT cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Nutritional status (Body Max Index calculated by Weight/(Height*Height), the weight expressed in Kg and, the height expressed in meters). Measurement time: at baseline, in every CT cycle and, 3 weeks after the third CT cycle. 2. Compliance with the planned chemotherapy schedule (Yes, No).Measurement time: at baseline, in every CT cycle and, 3 weeks after the third CT cycle. Safety variables 3. Adverse Events- AE. Measurement time: in every CT cycle and, 3 weeks after the third CT cycle. It will measure by: - Occurrence of some AE in the subject (Yes, No). -Type of AE (Description of AE using the Common Terminology Criteria for Adverse Events (CTCAE)-version 4.0) - Intensity of the AE: (Light, Moderate, Severe, Serious that threatens life or incapacitates the subject , Death). - Gravity of the AE (Serious, Not serious) - Duration of the AE (Difference of dates between the start and end of the event) - Attitude regarding the treatment under study (No changes, Dose modification, temporary interruption of the study treatment, Definitive interruption of the study treatment) - Result of the AE (Recovered, Improved, Persisted, Squeals) - Causality relationship (Very probable, Probable, Possible, Improbable, Unrelated, Not evaluable). 4. Laboratory tests (Hemoglobin-g/L, Hematocrit-%, Erythrocyte-109/l, Platelets-109/l, Leukocytes 109/l, Glycemia- mmol/l, Cholesterol-mmol/l, Triglycerides-mmol, Uric acid- µmol/l, Creatinine-mmol/l, Total and direct bilirubin-in µmol/l, Alkaline Phosphatase-U/L, ALT-U/L , AST-U/L, Total proteins- g/l, Albumin-g/l). Measurement time: at baseline, before second and third CT cycle and, 3 weeks after the third CT cycle. | — |
Countries
Cuba
Contacts
Public ContactRoselin Valle Cabrera
National Coordinator Center of Clinical Trials (CENCEC)
Outcome results
None listed