Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

NCT06015971 | Recruiting

• 1 other identifier: Sarcopenia omega3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcopenia

Keywords

cancer; nutritional support; omega-3 enriched nutritional supplements

Outcome Measures

Primary Outcomes (2)

• Muscle mass

  Muscle mass change (in Kg)

  12 weeks

• Functionality

  Changes in functionality measured with the Up and Go Test

  12 weeks

Secondary Outcomes (2)

• Albumin

  12 weeks

• C-RP

  12 weeks

Study Arms (2)

standard hypercaloric, hyperproteic oral supplement

ACTIVE COMPARATOR

Dietary Supplement: Standard

omega-3 enriched oral supplement

EXPERIMENTAL

Dietary Supplement: omega-3

Interventions

omega-3 DIETARY_SUPPLEMENT

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

omega-3 enriched oral supplement

Standard DIETARY_SUPPLEMENT

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

standard hypercaloric, hyperproteic oral supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

IMIBIC

Córdoba, Cordoba, 14004, Spain

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Neoplasms

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

ES (1)