Fish Oil Supplementation in Gastrointestinal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02699047
• Other study ID #: UFSC/04
• Status: Active, not recruiting
• Phase: N/A
• First received: February 12, 2016
• Last updated: June 29, 2016
• Start date: March 2015
• Est. completion date: July 2017

Study information

• Verified date: June 2016
• Source: Universidade Federal de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: July 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Stomach Cancer
• Stomach Neoplasms

Intervention

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).
• 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.

Locations

Country	Name	City	State
Brazil	Michel Carlos Mocellin	Florianopolis	Santa Catarina

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Santa Catarina	Centro de Pesquisas Oncológicas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Cytokines of inflammatory response	Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10)	Baseline, 5 and 9 weeks	No
Primary	Body weight	Assessment of weight (kg)	5 and 9 weeks	No
Primary	Body Mass Index (BMI)	Assessment of BMI (Kg/m²)	baseline, 5 and 9 weeks	No
Primary	Weight Change	Weight change in comparison with the weight at baseline (Kg)	baseline, 5 and 9 weeks	No
Primary	Fat mass	Fat mass assessment by electric bioimpedance (kg and %)	baseline and 9 weeks	No
Primary	Lean body mass	Lean body mass assessment by electric bioimpedance (kg and %)	baseline and 9 weeks	No
Primary	arm circumference	measurement of arm circumference using a inelastic metric tape (cm)	baseline, 5 and 9 weeks	No
Primary	tricipital skinfold	measurement of triciptal skinfold using a caliper (mm)	baseline, 5 and 9 weeks	No
Primary	Serum C-reactive protein	Serum quantification of C-reactive protein (mg/dL)	baseline, 5 and 9 weeks	No
Primary	Activity of Catalase	Quantification of erythrocyte catalase activity	Baseline and 9 weeks	No
Primary	Activity of Glutathione Peroxidase	Quantification of erythrocyte glutathione peroxidase activity	Baseline and 9 weeks	No
Primary	Activity of Superoxide Dismutase	Quantification of erythrocyte superoxide dismutase activity	Baseline and 9 weeks	No
Primary	Lipid Peroxidation	Evaluation of lipid hydroperoxides in plasma and leukocytes	Baseline and 9 weeks	No
Primary	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	No
Primary	Graduation of adverse events	Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment	Baseline, 5 weeks and 9 weeks	No
Primary	Tumor Markers	Quantification of serum tumor marker CEA and CA19	Baseline and 9 weeks	No
Primary	Survival	Evaluation of survival after 6 months and after one year of recruitment	Baseline, 6 months and one year	No
Primary	Serum albumin	Serum quantification of albumin (g/dL)	baseline, 5 weeks and 9 weeks	No