Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015971
• Other study ID #: Sarcopenia omega3
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Neoplasms
• Sarcopenia

Intervention

Dietary Supplement:
• omega-3
Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet
• Standard
Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet

Locations

Country	Name	City	State
Spain	IMIBIC	Cordoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	Muscle mass change (in Kg)	12 weeks
Primary	Functionality	Changes in functionality measured with the Up and Go Test	12 weeks
Secondary	Albumin	Changes in serum albumin levels (g/dl)	12 weeks
Secondary	C-RP	Changes in serum C-RP(g/dl)	12 weeks