Nutritional Therapy Enriched With Omega-3 in Patients With Lung Resection

July 29, 2024 updated by: Ivan Armando Osuna Padilla, National Institute of Respiratory Diseases, Mexico

Effect of Perioperative Nutrition Enriched With Omega-3 on the Incidence of Infections in Oncologic Patients Following Lung Resection

The aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

310

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 Contact

Study Contact Backup

  • Name: Ana L Gómez-Rodriguez, MSc
  • Phone Number: 5059 5487-1700
  • Email: grolucia@yahoo.es

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • Recruiting
        • National Institute of Respiratory Diseases
        • Contact:
          • Ana L Gomez-Rodriguez, MSc
          • Phone Number: +52 1 55 2573 2734
          • Email: grolucia@yahoo.es

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:

  • Lung cancer diagnosis
  • Elective surgery for lung resection schedule at least four days before surgery
  • Signed informed consent.

Exclusion Criteria:

  • Acute or chronic organ failure as hepatic or renal insufficiency
  • Patients with fish-allergy
  • History of any surgery within 3 months
  • Immunocompromised patients

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental enteral nutrition
Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer enriched enteral formula
Dietary supplement: Fish oil enteral supplementation
Omega-3 (4.2 g), administered through an enteral feeding tube, three days before surgery
Experimental: Experimental oral nutrition
Patients admitted one day before surgery. Home-self administration of enriched enteral formula three days before surgery
Dietary supplement: Fish oil oral supplementation
Omega-3 (4.2 g), orally administered enriched nutritional formula, drinking at home three days before surgery
Other: Standard enteral nutrition
Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer standard enteral formula
Dietary supplement: Enteral nutrition without fish oil
Enteral formula without omega-3 administered through an enteral feeding tube, three days before surgery
Other: Standard oral nutrition
Patients admitted one day before surgery. Home-self administration of standard enteral formula three days before surgery
Dietary supplement: Oral nutritional supplement without fish oil
Oral nutritional supplement without omega-3 orally administered, drinking at home three days before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day incidence infection
Time Frame: 30-day incidence infection following lung resection in lung cancer patients.

Incidence of infectious complications after surgery diagnosed using any of these criteria:

Infection of surgery wound confirmed by culture Infection confirmed by blood culture Pneumonia developed after surgery confirmed by chest x Ray.
30-day incidence infection following lung resection in lung cancer patients.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in prostaglandin E2
Time Frame: At the beginning of nutritional therapy and at day-4 following surgery
Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).
At the beginning of nutritional therapy and at day-4 following surgery
Changes in Interleukin-6
Time Frame: At the beginning of nutritional therapy and at day-4 following surgery
Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).
At the beginning of nutritional therapy and at day-4 following surgery
Changes in Tumor Necrosis Factor Alpha (TNF-α)
Time Frame: At the beginning of nutritional therapy and at day-4 following surgery
Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).
At the beginning of nutritional therapy and at day-4 following surgery
Number of participants with therapeutic antibiotics prescription
Time Frame: During the hospital stay until 30-day
Frequency of therapeutic antibiotics prescription will be collected from medical records and medication administration registers.
During the hospital stay until 30-day
Hospital lenght of stay
Time Frame: During the hospital stay until 90-day
Number of calendar days that elapsed since hospital admission to the day of hospital discharge
During the hospital stay until 90-day

Collaborators and Investigators

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

Sponsor

National Institute of Respiratory Diseases, Mexico

Investigators

  • Principal Investigator: Ivan A Osuna-Padilla, PhD, National Institute of Respiratory Diseases

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 25, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C34-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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