Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2015-03-31
2017-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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).
Control group
3.2 g/day of the olive oil (2 capsules/day) without n-3 polyunsaturated fatty acids
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Centro de Pesquisas Oncológicas
OTHER
Universidade Federal de Santa Catarina
OTHER
Responsible Party
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Erasmo Benicio Santos de Moraes Trindade
Ph.D. Professor
Locations
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Michel Carlos Mocellin
Florianópolis, Santa Catarina, Brazil
Countries
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References
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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.
Other Identifiers
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UFSC/04
Identifier Type: -
Identifier Source: org_study_id