Fish Oil Supplementation in Gastrointestinal Cancer
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|ClinicalTrials.gov Identifier: NCT02699047|
Recruitment Status : Unknown
Verified June 2016 by Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina.
Recruitment status was: Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : June 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancer Colorectal Cancer Stomach Cancer||Dietary Supplement: Encapsuled fish oil Dietary Supplement: Encapsulated Olive oil||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Gastrointestinal Cancer: Effects of the Fish Oil Intake on Nutritional Status, Quality of Life and Immune and Metabolic Outcomes|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||July 2017|
Experimental: 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
Dietary Supplement: Encapsuled 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).
Placebo Comparator: Control group
3.2 g/day of the olive oil (2 capsules/day) without n-3 polyunsaturated fatty acids
Dietary Supplement: Encapsulated 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.
- Change in Quality of life [ Time Frame: 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 [ Time Frame: Baseline, 5 and 9 weeks ]Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10)
- Body weight [ Time Frame: 5 and 9 weeks ]Assessment of weight (kg)
- Body Mass Index (BMI) [ Time Frame: baseline, 5 and 9 weeks ]Assessment of BMI (Kg/m²)
- Weight Change [ Time Frame: baseline, 5 and 9 weeks ]Weight change in comparison with the weight at baseline (Kg)
- Fat mass [ Time Frame: baseline and 9 weeks ]Fat mass assessment by electric bioimpedance (kg and %)
- Lean body mass [ Time Frame: baseline and 9 weeks ]Lean body mass assessment by electric bioimpedance (kg and %)
- arm circumference [ Time Frame: baseline, 5 and 9 weeks ]measurement of arm circumference using a inelastic metric tape (cm)
- tricipital skinfold [ Time Frame: baseline, 5 and 9 weeks ]measurement of triciptal skinfold using a caliper (mm)
- Serum C-reactive protein [ Time Frame: baseline, 5 and 9 weeks ]Serum quantification of C-reactive protein (mg/dL)
- Activity of Catalase [ Time Frame: Baseline and 9 weeks ]Quantification of erythrocyte catalase activity
- Activity of Glutathione Peroxidase [ Time Frame: Baseline and 9 weeks ]Quantification of erythrocyte glutathione peroxidase activity
- Activity of Superoxide Dismutase [ Time Frame: Baseline and 9 weeks ]Quantification of erythrocyte superoxide dismutase activity
- Lipid Peroxidation [ Time Frame: Baseline and 9 weeks ]Evaluation of lipid hydroperoxides in plasma and leukocytes
- Evaluation of adverse events consequences [ Time Frame: 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 [ Time Frame: Baseline, 5 weeks and 9 weeks ]Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment
- Tumor Markers [ Time Frame: Baseline and 9 weeks ]Quantification of serum tumor marker CEA and CA19
- Survival [ Time Frame: Baseline, 6 months and one year ]Evaluation of survival after 6 months and after one year of recruitment
- Serum albumin [ Time Frame: baseline, 5 weeks and 9 weeks ]Serum quantification of albumin (g/dL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699047
|Michel Carlos Mocellin|
|Florianopolis, Santa Catarina, Brazil|