Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer
Study Details
Study Description
Brief Summary
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients (arginine, glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate the activity of the immune system and provide an additional benefit beyond the nutritional support, this intervention type is called immunonutrition. Despite these possible benefits, their utility has been proven in few clinical scenarios, for example in with patients with upper gastrointestinal cancer undergoing surgical resection; based on this, current guidelines recommend that patients should receive oral/enteral nutritional support with an specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides) , but there is a lack of evidence for supporting its use in other clinical conditions including patients with cancer that receive systemic treatment
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: standard hypercaloric, hyperproteic oral supplement
|
Dietary Supplement: Standard
Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet
|
| Experimental: omega-3 enriched oral supplement
|
Dietary Supplement: omega-3
Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet
|
Outcome Measures
Primary Outcome Measures
- Muscle mass [12 weeks]
Muscle mass change (in Kg)
- Functionality [12 weeks]
Changes in functionality measured with the Up and Go Test
Secondary Outcome Measures
- Albumin [12 weeks]
Changes in serum albumin levels (g/dl)
- C-RP [12 weeks]
Changes in serum C-RP(g/dl)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Patients with Gastrointestinal tumor undergoing systemic treatment (chemo-radio-immuno therapy or their combination)
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Body weight loss >5% in the previous three months or >10% in the previous six months
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Both sexes
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Age between 18-85 y-old.
Exclusion Criteria:
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Life expectancy < 2 weeks
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MDRD < 15 mL/min
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End-stage liver disease
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Any musculoskeletal, cardiovascular and/or neurological disorders that could affect exercising.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IMIBIC | Cordoba | Spain | 14004 |
Sponsors and Collaborators
- Maimónides Biomedical Research Institute of Córdoba
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Sarcopenia omega3