Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

August 23, 2023 updated by: Maimónides Biomedical Research Institute of Córdoba

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard hypercaloric, hyperproteic oral supplement
Dietary supplement: Standard
Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet
Experimental: omega-3 enriched oral supplement
Dietary supplement: omega-3
Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass
Time Frame: 12 weeks
Muscle mass change (in Kg)
12 weeks
Functionality
Time Frame: 12 weeks
Changes in functionality measured with the Up and Go Test
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Albumin
Time Frame: 12 weeks
Changes in serum albumin levels (g/dl)
12 weeks
C-RP
Time Frame: 12 weeks
Changes in serum C-RP(g/dl)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sarcopenia omega3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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