NCT06015971 Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer
| NCT ID | NCT06015971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maimónides Biomedical Research Institute of Córdoba |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Frequently Asked Questions
Who can join the NCT06015971 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06015971 currently recruiting?
Yes, NCT06015971 is actively recruiting participants. Visit ClinicalTrials.gov or contact Maimónides Biomedical Research Institute of Córdoba to inquire about joining.
Where is the NCT06015971 trial being conducted?
This trial is being conducted at Córdoba, Spain.
Who is sponsoring the NCT06015971 clinical trial?
NCT06015971 is sponsored by Maimónides Biomedical Research Institute of Córdoba. The trial plans to enroll 40 participants.