Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

NCT ID: NCT06015971

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

standard hypercaloric, hyperproteic oral supplement

Group Type: ACTIVE_COMPARATOR

Standard

Intervention Type: DIETARY_SUPPLEMENT

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

omega-3 enriched oral supplement

Group Type: EXPERIMENTAL

omega-3

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

omega-3

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

Intervention Type: DIETARY_SUPPLEMENT

Standard

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IMIBIC

Córdoba, Cordoba, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Jose Carlos Garrido, PhD

Role: primary

josecarlos.garrido@imibic.org

957 213831

Other Identifiers

Sarcopenia omega3

Identifier Type: -

Identifier Source: org_study_id