Clinical trial NCT02699047: Fish Oil Supplementation in Gastrointestinal Cancer
Official title: Gastrointestinal Cancer: Effects of the Fish Oil Intake on Nutritional Status, Quality of Life and Immune and Metabolic Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Cancer
Colorectal Cancer
Stomach Cancer
Keywords: Gastrointestinal cancer
Fish oil
Oxidative stress
Inflammation
Quality of life
Nutritional status
Colorectal cancer
Stomach cancer
Chemotherapy
polyunsaturated fatty acids n-3
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
Collaborators: name: Centro de Pesquisas Oncológicas
First posted: 2016-03-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of life
timeFrame: baseline and 9 weeks (final moment)
measure: Cytokines of inflammatory response
timeFrame: Baseline, 5 and 9 weeks
measure: Body weight
timeFrame: 5 and 9 weeks
measure: Body Mass Index (BMI)
timeFrame: baseline, 5 and 9 weeks
measure: Weight Change
timeFrame: baseline, 5 and 9 weeks
measure: Fat mass
timeFrame: baseline and 9 weeks
measure: Lean body mass
timeFrame: baseline and 9 weeks
measure: arm circumference
timeFrame: baseline, 5 and 9 weeks
measure: tricipital skinfold
timeFrame: baseline, 5 and 9 weeks
measure: Serum C-reactive protein
timeFrame: baseline, 5 and 9 weeks
measure: Activity of Catalase
timeFrame: Baseline and 9 weeks
measure: Activity of Glutathione Peroxidase
timeFrame: Baseline and 9 weeks
measure: Activity of Superoxide Dismutase
timeFrame: Baseline and 9 weeks
measure: Lipid Peroxidation
timeFrame: Baseline and 9 weeks
measure: Evaluation of adverse events consequences
timeFrame: Baseline and 9 weeks
measure: Graduation of adverse events
timeFrame: Baseline, 5 weeks and 9 weeks
measure: Tumor Markers
timeFrame: Baseline and 9 weeks
measure: Survival
timeFrame: Baseline, 6 months and one year
measure: Serum albumin
timeFrame: baseline, 5 weeks and 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Michel Carlos Mocellin
state: Santa Catarina
Study officials:
References:
citation: 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.