Fish Oil Supplementation in Gastrointestinal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gastrointestinal Cancer: Effects of the Fish Oil Intake on Nutritional Status, Quality of Life and Immune and Metabolic Outcomes

Conditions
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Gastrointestinal Cancer, Colorectal Cancer, Stomach Cancer

Intervention / Treatment
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* Dietary Supplement: Encapsuled fish oil
* Dietary Supplement: Encapsulated Olive oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil<br>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 | Dietary Supplement: Encapsuled fish oil<br>* 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).<br>|
| Placebo Comparator: Control group<br>3.2 g/day of the olive oil (2 capsules/day) without n-3 polyunsaturated fatty acids | Dietary Supplement: Encapsulated Olive oil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and 9 weeks (final moment) | 
| Cytokines of inflammatory response | Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10) | Baseline, 5 and 9 weeks | 
| Body weight | Assessment of weight (kg) | 5 and 9 weeks | 
| Body Mass Index (BMI) | Assessment of BMI (Kg/m²) | baseline, 5 and 9 weeks | 
| Weight Change | Weight change in comparison with the weight at baseline (Kg) | baseline, 5 and 9 weeks | 
| Fat mass | Fat mass assessment by electric bioimpedance (kg and %) | baseline and 9 weeks | 
| Lean body mass | Lean body mass assessment by electric bioimpedance (kg and %) | baseline and 9 weeks | 
| arm circumference | measurement of arm circumference using a inelastic metric tape (cm) | baseline, 5 and 9 weeks | 
| tricipital skinfold | measurement of triciptal skinfold using a caliper (mm) | baseline, 5 and 9 weeks | 
| Serum C-reactive protein | Serum quantification of C-reactive protein (mg/dL) | baseline, 5 and 9 weeks | 
| Activity of Catalase | Quantification of erythrocyte catalase activity | Baseline and 9 weeks | 
| Activity of Glutathione Peroxidase | Quantification of erythrocyte glutathione peroxidase activity | Baseline and 9 weeks | 
| Activity of Superoxide Dismutase | Quantification of erythrocyte superoxide dismutase activity | Baseline and 9 weeks | 
| Lipid Peroxidation | Evaluation of lipid hydroperoxides in plasma and leukocytes | 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) | Baseline and 9 weeks | 
| Graduation of adverse events | Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment | Baseline, 5 weeks and 9 weeks | 
| Tumor Markers | Quantification of serum tumor marker CEA and CA19 | Baseline and 9 weeks | 
| Survival | Evaluation of survival after 6 months and after one year of recruitment | Baseline, 6 months and one year | 
| Serum albumin | Serum quantification of albumin (g/dL) | baseline, 5 weeks and 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal cancer, Fish oil, Oxidative stress, Inflammation, Quality of life, Nutritional status, Colorectal cancer, Stomach cancer, Chemotherapy, polyunsaturated fatty acids n-3