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

Not Applicable

Recruiting

• Conditions: Lung Cancer; Surgery

• 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

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