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NCT Number: NCT06015971

Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMIBIC

Córdoba, Cordoba, 14004, Spain

Location status: Recruiting

Location contact

Jose Carlos Garrido, PhD

CONTACT

[email protected]

957 213831

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Muscle mass

    Time frame: 12 weeks

    Muscle mass change (in Kg)

  2. Functionality

    Time frame: 12 weeks

    Changes in functionality measured with the Up and Go Test

Secondary outcomes

  1. Albumin

    Time frame: 12 weeks

    Changes in serum albumin levels (g/dl)

  2. C-RP

    Time frame: 12 weeks

    Changes in serum C-RP(g/dl)

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Official study title

Omega-3 Enriched Supplements in the Nutritional Support of Patients With Gastrointestinal Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2023
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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