About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Patients with Gastrointestinal tumor undergoing systemic treatment (chemo-radio-immuno therapy or their combination)
Body weight loss >5% in the previous three months or >10% in the previous six months
Both sexes
Age between 18-85 y-old.
Disqualifiers
Life expectancy < 2 weeks
MDRD < 15 mL/min
End-stage liver disease
Any musculoskeletal, cardiovascular and/or neurological disorders that could affect exercising.
Trial design
Parallel
Treatments tested in this trial
omega-3
Dietary supplementTake 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet
Standard
Dietary supplementTake 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet
Treatment groups
Trial outcomes
Primary outcomes
Muscle mass
Muscle mass change (in Kg)
Functionality
Changes in functionality measured with the Up and Go Test
Secondary outcomes
Albumin
Changes in serum albumin levels (g/dl)
C-RP
Changes in serum C-RP(g/dl)
Sponsors and contacts
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