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

NCT ID: NCT06531460

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-25

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Use of enteral formula enriched with omega-3 or standard not revealed for participants.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Fish oil enteral supplementation

Intervention Type DIETARY_SUPPLEMENT

Omega-3 (4.2 g), administered through an enteral feeding tube, three days before surgery

Experimental oral nutrition

Patients admitted one day before surgery. Home-self administration of enriched enteral formula three days before surgery

Group Type EXPERIMENTAL

Fish oil oral supplementation

Intervention Type DIETARY_SUPPLEMENT

Omega-3 (4.2 g), orally administered enriched nutritional formula, drinking at home three days before surgery

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

Group Type OTHER

Enteral nutrition without fish oil

Intervention Type DIETARY_SUPPLEMENT

Enteral formula without omega-3 administered through an enteral feeding tube, three days before surgery

Standard oral nutrition

Patients admitted one day before surgery. Home-self administration of standard enteral formula three days before surgery

Group Type OTHER

Oral nutritional supplement without fish oil

Intervention Type DIETARY_SUPPLEMENT

Oral nutritional supplement without omega-3 orally administered, drinking at home three days before surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fish oil enteral supplementation

Omega-3 (4.2 g), administered through an enteral feeding tube, three days before surgery

Intervention Type DIETARY_SUPPLEMENT

Fish oil oral supplementation

Omega-3 (4.2 g), orally administered enriched nutritional formula, drinking at home three days before surgery

Intervention Type DIETARY_SUPPLEMENT

Enteral nutrition without fish oil

Enteral formula without omega-3 administered through an enteral feeding tube, three days before surgery

Intervention Type DIETARY_SUPPLEMENT

Oral nutritional supplement without fish oil

Oral nutritional supplement without omega-3 orally administered, drinking at home three days before surgery

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Respiratory Diseases, Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ivan Armando Osuna Padilla

Clinical Nutrition Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ivan A Osuna-Padilla, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Enfermedades Respiratorias

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institute of Respiratory Diseases

Mexico City, , Mexico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ivan A Osuna-Padilla, PhD

Role: CONTACT

5487-1700 ext. 5059

Ana L Gómez-Rodriguez, MSc

Role: CONTACT

5487-1700 ext. 5059

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ana L Gomez-Rodriguez, MSc

Role: primary

+52 1 55 2573 2734

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C34-24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.