Health TrialsbyHealthPanel

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

ConditionsLung CancerSurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Respiratory Diseases, Mexico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Lung cancer diagnosis

Elective surgery for lung resection schedule at least four days before surgery

Signed informed consent.

Disqualifiers

Acute or chronic organ failure as hepatic or renal insufficiency

Patients with fish-allergy

History of any surgery within 3 months

Immunocompromised patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

310 Participants
are divided into 4 treatment groups
Group A: Experimental enteral nutritionExperimental treatment 1 intervention
Group B: Experimental oral nutritionExperimental treatment 1 intervention
Group C: Standard enteral nutritionOther 1 intervention
Group D: Standard oral nutritionOther 1 intervention

Trial outcomes

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.

Time frame
30-day incidence infection following lung resection in lung cancer patients.

Secondary outcomes

1

Changes in prostaglandin E2

Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).

Time frame
At the beginning of nutritional therapy and at day-4 following surgery
2

Changes in Interleukin-6

Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).

Time frame
At the beginning of nutritional therapy and at day-4 following surgery
3

Changes in Tumor Necrosis Factor Alpha (TNF-α)

Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).

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

Number of participants with therapeutic antibiotics prescription

Frequency of therapeutic antibiotics prescription will be collected from medical records and medication administration registers.

Time frame
During the hospital stay until 30-day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Respiratory Diseases, Mexico

Lead sponsor

Source ClinicalTrials.gov
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