Olive Oil Before Lung Cancer Surgery to Prevent Chylothorax
Recruiting · NCT07807696 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Fudan University Shanghai Cancer Center - Shanghai, Xuhui, China