Clinical trial · Interventional
Olive Oil Before Lung Cancer Surgery to Prevent Chylothorax
A Multicenter, Prospective, Randomized Controlled Trial of Preoperative Oral Olive Oil for the Prevention of Postoperative Chylothorax in Patients With Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
Chylothorax is a rare but serious complication after lung cancer surgery and mediastinal lymph node dissection. This multicenter randomized trial will evaluate whether drinking 40 mL of extra-virgin olive oil 4 hours before surgery can reduce the occurrence of chylothorax after curative lung cancer resection. A total of 1,036 adults with resectable lung cancer will be assigned in a 1:1 ratio to preoperative oral olive oil or standard preoperative fasting without additional olive oil. The primary outcome is the occurrence of chylothorax within 30 days after surgery. Secondary outcomes include repeat surgery, postoperative complications, chest drainage, length of chest tube use, length of hospital stay, and the safety and tolerability of the intervention.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chylothorax | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extra-Virgin Olive Oil | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preoperative Olive Oil
- description
- Participants drink 40 mL of extra-virgin olive oil 4 hours before surgery and then continue fasting from food and water until surgery.
- interventionNames
- Dietary Supplement: Extra-Virgin Olive Oil
- type
- NO_INTERVENTION
- label
- Standard Preoperative Fasting
- description
- Participants follow each center's standard preoperative fasting regimen: no food for 8 hours and no water for 2 hours before surgery. No additional olive oil is given.
Primary outcomes (1)
- measure
- Incidence of Postoperative Chylothorax
- timeFrame
- Within 30 days after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary participation and willing and able to complete all study procedures. * Age 18 to 80 years, inclusive, at informed consent. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Resectable lung cancer. * No prior surgery for lung cancer. * Treatment-naive and no prior radiotherapy or chemotherapy. * Able to take food orally before surgery. Exclusion Criteria: * Allergy to olive oil or any of its components. * History of acute or chronic pancreatitis or severe biliary disease. * Fat malabsorption syndrome. * Prior ipsilateral thoracic surgery or thoracic radiotherapy or chemotherapy. * Unable to comply with preoperative dietary instructions.
References
Publications (0)
Data not yet available