Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

ConditionSarcopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaimónides Biomedical Research Institute of Córdoba

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 volunteers

Qualifiers

- 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

Design model

Parallel

Treatments tested in this trial

  • omega-3

    Dietary supplement

    Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet

  • Standard

    Dietary supplement

    Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: standard hypercaloric, hyperproteic oral supplementActive comparator 1 intervention
Group B: omega-3 enriched oral supplementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Muscle mass

Muscle mass change (in Kg)

Time frame
12 weeks
2

Functionality

Changes in functionality measured with the Up and Go Test

Time frame
12 weeks

Secondary outcomes

1

Albumin

Changes in serum albumin levels (g/dl)

Time frame
12 weeks
2

C-RP

Changes in serum C-RP(g/dl)

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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