Lung Cancer, Surgery
Conditions
Keywords
lung cancer, omega-3, prehabilitation nutrition, perioperative nutrition, infections, inflammation response
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.
Interventions
DIETARY_SUPPLEMENTFish oil enteral supplementation
Omega-3 (4.2 g), administered through an enteral feeding tube, three days before surgery
DIETARY_SUPPLEMENTFish oil oral supplementation
Omega-3 (4.2 g), orally administered enriched nutritional formula, drinking at home three days before surgery
DIETARY_SUPPLEMENTEnteral nutrition without fish oil
Enteral formula without omega-3 administered through an enteral feeding tube, three days before surgery
DIETARY_SUPPLEMENTOral nutritional supplement without fish oil
Oral nutritional supplement without omega-3 orally administered, drinking at home three days before surgery
Sponsors
National Institute of Respiratory Diseases, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Use of enteral formula enriched with omega-3 or standard not revealed for participants.
Intervention model description
Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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. |
| 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 |
Countries
Mexico
Contacts
Primary ContactIvan A Osuna-Padilla, PhD
Backup ContactAna L Gómez-Rodriguez, MSc
Outcome results
None listed