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NCT Number: NCT06531460

Nutritional Therapy Enriched With Omega-3 in Patients With 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.

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Key information

Conditions

Lung Cancer Infections Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Surgery Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Respiratory Diseases

Mexico City, 14080, Mexico

Location status: Recruiting

Location contact

Ana L Gomez-Rodriguez, MSc

CONTACT

[email protected]

+52 1 55 2573 2734

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish oil enteral supplementation

Dietary Supplement

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

Fish oil oral supplementation

Dietary Supplement

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

Enteral nutrition without fish oil

Dietary Supplement

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

Oral nutritional supplement without fish oil

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ana L Gómez-Rodriguez, MSc

CONTACT

[email protected]

5487-1700 ext. 5059

Ivan A Osuna-Padilla, PhD

CONTACT

[email protected]

5487-1700 ext. 5059

Sponsors and collaborators

Lead sponsor

National Institute of Respiratory Diseases, Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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