Fish Oil Supplementation in Gastrointestinal Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Stomach Cancer; Colorectal Cancer; Gastrointestinal Cancer
• Intervention / Treatment: Dietary supplement: Encapsuled fish oil; Dietary supplement: Encapsulated Olive oil

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Florianopolis, Santa Catarina, Brazil
      • Michel Carlos Mocellin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Catarina
• Collaborators: Centro de Pesquisas Oncológicas

Publications and helpful links

General Publications

• Camargo CQ, Mocellin MC, Brunetta HS, Chagas TR, Fabre MES, Trindade EBSM, Silva ELD, Nunes EA. Fish oil decreases the severity of treatment-related adverse events in gastrointestinal cancer patients undergoing chemotherapy: A randomized, placebo-controlled, triple-blind clinical trial. Clin Nutr ESPEN. 2019 Jun;31:61-70. doi: 10.1016/j.clnesp.2019.02.015. Epub 2019 Mar 14.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 27, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Oxidative stress; Inflammation; Colorectal cancer; Quality of life; Chemotherapy; Nutritional status; Fish oil; Stomach cancer; Gastrointestinal cancer; polyunsaturated fatty acids n-3
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Stomach Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms
• Other Study ID Numbers: UFSC/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No