Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
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
Key secondary outcomes:
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.