Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06015971

Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

Led by Maimónides Biomedical Research Institute of Córdoba · Updated on 2025-05-06

40

Participants Needed

1

Research Sites

182 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Life expectancy < 2 weeks
  • MDRD < 15 mL/min
  • End-stage liver disease
  • Any musculoskeletal, cardiovascular and/or neurological disorders that could affect exercising.

AI-Screening

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Trial Site Locations

Total: 1 location

1

IMIBIC

Córdoba, Cordoba, Spain, 14004

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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