Double-blind, randomized clinical trial to assess the effects of 1,55 g/day of n-3 fatty acids from fish oil concomitant chemotherapy in gastrointestinal cancer.
This study will be divided into three stages defined as: baseline (T0), middle moment (T1) and final moment (T2). At baseline, will be performer the patients identification, clinical data collection, assessment of anthropometric data and body composition, blood sample collection and questionnaires application for individuals allocated into two groups (Fish Oil Group and Placebo Group). The Fish Oil Group (GOP) will receive fish oil capsules and the placebo group (GP) will receive capsules containing olive oil, both also will receive consumption guidelines. The list of randomization was generated by a computer program and was divided by cancer localization and gender. The researchers involved with the recruitment had access only to randomization list containing codes. The codes were distributed sequentially. The baseline is the day of first chemotherapy. In the middle moment, five weeks after the start of study, new blood collection, questionnaires and measurement of anthropometric data will be performed. At the final moment, nine weeks after baseline, last blood collection, questionnaires and measurement of anthropometric data and body composition of fish oil and placebo groups will be performed, and will feature the end of the capsules consumption. After 6 months and 1 year after the initiation of chemotherapy and supplementation with fish oil or placebo, survival data will be collected. Throughout the monitoring period, the researcher and collaborators will maintain contact with the individuals included. The contact will be made in CEPON, where they receive chemotherapy, and by telephone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Fish oil extracted from sardine, mackerel and anchovy. Nutritional information per capsule: Kcal: 13; protein: 0.35g; Total Fats: 1.25g; Saturated fat: 0g; polyunsaturated fat: 0.75g; EPA: 0.5g; DHA: 0.25g; Cholesterol: 0g. The supplement was provided in gelatinous capsule with antioxidant (tocopherols).
Extra virgin olive oil. Nutritional information per capsule: Kcal: 10; protein: 0.35g; Total Fats: 1g; Saturated fat: 0.1 g; monounsaturated fat: 0.75g; polyunsaturated fat: 0.1g; EPA: 0g; DHA: 0g; oleic acid: 0.65g; Cholesterol: 0g. The supplement was provided in gelatinous capsule without antioxidants.
Michel Carlos Mocellin
Florianópolis, Santa Catarina, Brazil
Change in Quality of life
Application by interview of the EORTC QOL questionnaires: QLQ-C30 v. 3.0; CRC-29 and STO22. The change was observed by increase ou decrease in overall score of the scales.
Time frame: baseline and 9 weeks (final moment)
Cytokines of inflammatory response
Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10)
Time frame: Baseline, 5 and 9 weeks
Body weight
Assessment of weight (kg)
Time frame: 5 and 9 weeks
Body Mass Index (BMI)
Assessment of BMI (Kg/m²)
Time frame: baseline, 5 and 9 weeks
Weight Change
Weight change in comparison with the weight at baseline (Kg)
Time frame: baseline, 5 and 9 weeks
Fat mass
Fat mass assessment by electric bioimpedance (kg and %)
Time frame: baseline and 9 weeks
Lean body mass
Lean body mass assessment by electric bioimpedance (kg and %)
Time frame: baseline and 9 weeks
arm circumference
measurement of arm circumference using a inelastic metric tape (cm)
Time frame: baseline, 5 and 9 weeks
tricipital skinfold
measurement of triciptal skinfold using a caliper (mm)
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Time frame: baseline, 5 and 9 weeks
Serum C-reactive protein
Serum quantification of C-reactive protein (mg/dL)
Time frame: baseline, 5 and 9 weeks
Activity of Catalase
Quantification of erythrocyte catalase activity
Time frame: Baseline and 9 weeks
Activity of Glutathione Peroxidase
Quantification of erythrocyte glutathione peroxidase activity
Time frame: Baseline and 9 weeks
Activity of Superoxide Dismutase
Quantification of erythrocyte superoxide dismutase activity
Time frame: Baseline and 9 weeks
Lipid Peroxidation
Evaluation of lipid hydroperoxides in plasma and leukocytes
Time frame: Baseline and 9 weeks
Evaluation of adverse events consequences
Evaluation of changes in treatment protocol due to adverse events (hospitalizations, treatment interruption, delay of treatment administration, dose reductions)
Time frame: Baseline and 9 weeks
Graduation of adverse events
Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment
Time frame: Baseline, 5 weeks and 9 weeks
Tumor Markers
Quantification of serum tumor marker CEA and CA19
Time frame: Baseline and 9 weeks
Survival
Evaluation of survival after 6 months and after one year of recruitment
Time frame: Baseline, 6 months and one year
Serum albumin
Serum quantification of albumin (g/dL)
Time frame: baseline, 5 weeks and 9 weeks