Lung CancerECTOP-1031NCT07807696
Olive Oil Before Lung Cancer Surgery to Prevent Chylothorax
A study testing Extra-Virgin Olive Oil in people with Lung Cancer and Chylothorax, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Chylothorax
- What is being tested?
- Extra-Virgin Olive Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,036 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Xuhui, 200000
Yang Zhang, MD, 86-18717722753, 16301050173@fudan.edu.cn
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Trial of Preoperative Oral Olive Oil for the Prevention of Postoperative Chylothorax in Patients With Lung Cancer
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
- Lung Cancer, Chylothorax
- Being tested
- Extra-Virgin Olive Oil
- Keywords
- Olive Oil, Thoracic Duct, Postoperative Complications
- Medical subject headings
- Lung Neoplasms, Chylothorax, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-Virgin Olive OilDietary supplement
A single 40 mL dose of extra-virgin olive oil is taken orally 4 hours before curative lung cancer surgery. After ingestion, participants continue fasting from food and water until surgery.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Olive Oil | Experimental | Participants drink 40 mL of extra-virgin olive oil 4 hours before surgery and then continue fasting from food and water until surgery. Receives: Dietary Supplement: Extra-Virgin Olive Oil |
| Standard Preoperative Fasting | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Chylothorax
Percentage of participants diagnosed with postoperative chylothorax. Chylothorax is defined as pleural drainage fluid triglycerides greater than 110 mg/dL (1.2 mmol/L) or a typical milky appearance of pleural drainage after resumption of oral dietary fat.
Measured: Within 30 days after surgery
Secondary outcomes (1)
Incidence of Postoperative Complications
Percentage of participants with one or more surgery-related postoperative complications, including prolonged air leak, atrial fibrillation or other arrhythmia, postoperative bleeding, pulmonary infection, respiratory insufficiency, bronchopleural fistula, pneumothorax or atelectasis, recurrent laryngeal nerve injury, or death.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Mar 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,036 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807696
- Sponsor's protocol ID
- ECTOP-1031
- Other IDs
- 2602-Exp386
- Acronym
- ECTOP-1031
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Trial of Preoperative Oral Olive Oil for the Prevention of Postoperative Chylothorax in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT07807696
- Acronym / sponsor ID
- ECTOP-1031 / ECTOP-1031
- Conditions
- Lung Cancer, Chylothorax
- Keywords
- Olive Oil, Thoracic Duct, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,036 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Olive Oil | Experimental | Dietary Supplement: Extra-Virgin Olive OilParticipants drink 40 mL of extra-virgin olive oil 4 hours before surgery and then continue fasting from food and water until surgery. |
| Standard Preoperative Fasting | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-Virgin Olive OilA single 40 mL dose of extra-virgin olive oil is taken orally 4 hours before curative lung cancer surgery. After ingestion, participants continue fasting from food and water until surgery. | Dietary supplement | Preoperative Olive Oil |
Primary outcome
Incidence of Postoperative Chylothorax
Time frame: Within 30 days after surgery
Percentage of participants diagnosed with postoperative chylothorax. Chylothorax is defined as pleural drainage fluid triglycerides greater than 110 mg/dL (1.2 mmol/L) or a typical milky appearance of pleural drainage after resumption of oral dietary fat.
1 secondary outcome
Incidence of Postoperative Complications
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra-Virgin Olive Oil in people with Lung Cancer and Chylothorax, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hang Cao, MD (+86 18717722753, 16301050173@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Chylothorax (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.