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

NCT06531460 | Recruiting

• 1 other identifier: C34-24
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Surgery

Keywords

lung cancer; omega-3; prehabilitation nutrition; perioperative nutrition; infections; inflammation response

Outcome Measures

Primary Outcomes (1)

• 30-day incidence infection

  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 Outcomes (5)

• Changes in prostaglandin E2

  At the beginning of nutritional therapy and at day-4 following surgery

• Changes in Interleukin-6

  At the beginning of nutritional therapy and at day-4 following surgery

• Changes in Tumor Necrosis Factor Alpha (TNF-α)

  At the beginning of nutritional therapy and at day-4 following surgery

• Number of participants with therapeutic antibiotics prescription

  During the hospital stay until 30-day

• Hospital lenght of stay

  During the hospital stay until 90-day

Study Arms (4)

Experimental enteral nutrition

EXPERIMENTAL

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

Experimental oral nutrition

EXPERIMENTAL

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

Dietary Supplement: Fish oil oral supplementation

Standard enteral nutrition

OTHER

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

Standard oral nutrition

OTHER

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

Interventions

Fish oil enteral supplementation DIETARY_SUPPLEMENT

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

Experimental enteral nutrition

Fish oil oral supplementation DIETARY_SUPPLEMENT

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

Experimental oral nutrition

Enteral nutrition without fish oil DIETARY_SUPPLEMENT

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

Standard enteral nutrition

Oral nutritional supplement without fish oil DIETARY_SUPPLEMENT

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

Standard oral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

National Institute of Respiratory Diseases

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Infections

Interventions

Enteral Nutrition; Fish Oils; Dietary Supplements

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Oils; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ivan A Osuna-Padilla, PhD

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan A Osuna-Padilla, PhD

CONTACT

5487-1700; ivan.osuna@iner.gob.mx

Ana L Gómez-Rodriguez, MSc

CONTACT

5487-1700; grolucia@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Use of enteral formula enriched with omega-3 or standard not revealed for participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nutrition Manager

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 1, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)