Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

Trial Title: Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

NCT ID: NCT06015971

Condition: Sarcopenia

Conditions: Official terms:
Gastrointestinal Neoplasms
Sarcopenia

Conditions: Keywords:
cancer
nutritional support
omega-3 enriched nutritional supplements

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Dietary Supplement
Intervention name: omega-3
Description: Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet
Arm group label: omega-3 enriched oral supplement

Intervention type: Dietary Supplement
Intervention name: Standard
Description: Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet
Arm group label: standard hypercaloric, hyperproteic oral supplement

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

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: IMIBIC

Address:
City: Cordoba
Zip: 14004
Country: Spain

Status: Recruiting

Contact:
Last name: Jose Carlos Garrido, PhD

Phone: 957 213831
Email: josecarlos.garrido@imibic.org

Start date: July 1, 2023

Completion date: June 30, 2024

Lead sponsor:
Agency: Maimónides Biomedical Research Institute of Córdoba
Agency class: Other

Source: Maimónides Biomedical Research Institute of Córdoba

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06015971