Colorectal Cancer, Gastrointestinal Cancer, Stomach Cancer
Conditions
Keywords
Gastrointestinal cancer, Fish oil, Oxidative stress, Inflammation, Quality of life, Nutritional status, Colorectal cancer, Stomach cancer, Chemotherapy, polyunsaturated fatty acids n-3
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.
Interventions
DIETARY_SUPPLEMENTEncapsulated Olive oil
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.
DIETARY_SUPPLEMENTEncapsuled fish oil
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).
Sponsors
Centro de Pesquisas Oncológicas
Universidade Federal de Santa Catarina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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) |
Countries
Brazil
Outcome results
None listed