Fish Oil Supplementation in Gastrointestinal Cancer
- Conditions
- Gastrointestinal CancerColorectal CancerStomach Cancer
- Interventions
- Dietary Supplement: Encapsulated Olive oilDietary Supplement: Encapsuled fish oil
- Registration Number
- NCT02699047
- Lead Sponsor
- Universidade Federal de Santa Catarina
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- Individuals with age between 18 to 70 y.
- Histopathological diagnosis of gastric cancer, or colorectal or anal canal or intestinal cancer
- Ability to start chemotherapy in institution (CEPON)
- Performance status <= 2
- Prior chemotherapy
- Inability to oral intake
- diagnosis of infectious or inflammatory disease or diabetes
- Allergy to fish and / or derivatives,
- Pregnant,
- Treatment with statins or anti-inflammatories drugs
- Intake of fish oil and/or another supplement containing omega-3 or other polyunsaturated fatty acid in the six months prior their inclusion in the study
- Continued use of supplements containing antioxidants
- Patients in palliative care
- without cognitive ability to perform the study protocol
- Enrolled in studies with new drugs
- Hospitalized patients at recruitment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Encapsulated Olive oil 3.2 g/day of the olive oil (2 capsules/day) without n-3 polyunsaturated fatty acids Fish oil Encapsuled fish oil 3.6 g/day of the encapsulated fish oil (2 capsules/day) providing 1.55 g/d of the n-3 polyunsaturated fatty acids (EPA and DHA) during 9 weeks
- Primary Outcome Measures
Name Time Method Fat mass baseline and 9 weeks Fat mass assessment by electric bioimpedance (kg and %)
Lean body mass baseline and 9 weeks Lean body mass assessment by electric bioimpedance (kg and %)
arm circumference baseline, 5 and 9 weeks measurement of arm circumference using a inelastic metric tape (cm)
tricipital skinfold baseline, 5 and 9 weeks measurement of triciptal skinfold using a caliper (mm)
Serum C-reactive protein baseline, 5 and 9 weeks Serum quantification of C-reactive protein (mg/dL)
Activity of Catalase Baseline and 9 weeks Quantification of erythrocyte catalase activity
Activity of Glutathione Peroxidase Baseline and 9 weeks Quantification of erythrocyte glutathione peroxidase activity
Change in Quality of life baseline and 9 weeks (final moment) 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.
Cytokines of inflammatory response Baseline, 5 and 9 weeks Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10)
Body weight 5 and 9 weeks Assessment of weight (kg)
Body Mass Index (BMI) baseline, 5 and 9 weeks Assessment of BMI (Kg/m²)
Weight Change baseline, 5 and 9 weeks Weight change in comparison with the weight at baseline (Kg)
Activity of Superoxide Dismutase Baseline and 9 weeks Quantification of erythrocyte superoxide dismutase activity
Lipid Peroxidation Baseline and 9 weeks Evaluation of lipid hydroperoxides in plasma and leukocytes
Evaluation of adverse events consequences Baseline and 9 weeks Evaluation of changes in treatment protocol due to adverse events (hospitalizations, treatment interruption, delay of treatment administration, dose reductions)
Graduation of adverse events Baseline, 5 weeks and 9 weeks Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment
Tumor Markers Baseline and 9 weeks Quantification of serum tumor marker CEA and CA19
Survival Baseline, 6 months and one year Evaluation of survival after 6 months and after one year of recruitment
Serum albumin baseline, 5 weeks and 9 weeks Serum quantification of albumin (g/dL)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Michel Carlos Mocellin
🇧🇷Florianopolis, Santa Catarina, Brazil