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

Not Applicable

Recruiting

• Conditions: Lung Cancer; Surgery
• Interventions: Dietary Supplement: Fish oil oral supplementation; Dietary Supplement: Enteral nutrition without fish oil; Dietary Supplement: Oral nutritional supplement without fish oil; Dietary Supplement: Fish oil enteral supplementation

• Registration Number: NCT06531460
• Lead Sponsor: National Institute of Respiratory Diseases, Mexico

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-25
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-12
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 310

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental oral nutrition	Fish oil oral supplementation	Patients admitted one day before surgery. Home-self administration of enriched enteral formula three days before surgery
Standard enteral nutrition	Enteral nutrition without fish oil	Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer standard enteral formula
Standard oral nutrition	Oral nutritional supplement without fish oil	Patients admitted one day before surgery. Home-self administration of standard enteral formula three days before surgery
Experimental enteral nutrition	Fish oil enteral supplementation	Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer enriched enteral formula

Primary Outcome Measures

Name	Time	Method
30-day incidence infection	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Institute of Respiratory Diseases; 🇲🇽 Mexico City, Mexico