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

National Institute of Respiratory Diseases, Mexico

Status: Enrolling

Conditions: Surgery; Lung Cancer

Treatments: Dietary Supplement: Fish oil oral supplementation; Dietary Supplement: Enteral nutrition without fish oil; Dietary Supplement: Fish oil enteral supplementation; Dietary Supplement: Oral nutritional supplement without fish oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06531460

C34-24

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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310 participants in 4 patient groups

Experimental enteral nutrition

Experimental group

Description:

Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer enriched enteral formula

Treatment:

Dietary Supplement: Fish oil enteral supplementation

Experimental oral nutrition

Experimental group

Description:

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

Treatment:

Dietary Supplement: Fish oil oral supplementation

Standard enteral nutrition

Other group

Description:

Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer standard enteral formula

Treatment:

Dietary Supplement: Enteral nutrition without fish oil

Standard oral nutrition

Other group

Description:

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

Treatment:

Dietary Supplement: Oral nutritional supplement without fish oil