Fish Oil Supplementation in Gastrointestinal Cancer

Universidade Federal de Santa Catarina

Status: Unknown

Conditions: Gastrointestinal Cancer; Stomach Cancer; Colorectal Cancer

Treatments: Dietary Supplement: Encapsulated Olive oil; Dietary Supplement: Encapsuled fish oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02699047

UFSC/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Fish oil

Experimental group

Description:

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

Treatment:

Dietary Supplement: Encapsuled fish oil

Control group

Placebo Comparator group

Description:

3.2 g/day of the olive oil (2 capsules/day) without n-3 polyunsaturated fatty acids

Treatment:

Dietary Supplement: Encapsulated Olive oil