Blocking stress and inflammation around surgery to slow ovarian cancer spread
Inhibiting Beta-adrenergic and COX-2 Signaling During the Perioperative Period to Reduce Ovarian Cancer Progression: A Randomized Placebo-Controlled Clinical Trial
This trial will try giving propranolol and etodolac around the time of debulking surgery to lower recurrence and boost immune responses in women with suspected high-grade ovarian cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | Female |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Ramat Gan and 1 other locations) |
| Trial ID | NCT06839144 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 2 trial enrolls 60 women undergoing primary or interval debulking for suspected high-grade ovarian epithelial cancer. Participants are randomized to perioperative propranolol plus etodolac or matching placebo, with propranolol started five days before surgery, increased on the day of surgery, and continued postoperatively at a fixed etodolac dose. Primary outcomes focus on feasibility measures—recruitment, drug safety, tolerability, and adherence—and on molecular tumor and blood changes; secondary outcomes include three-year recurrence rates. The design tests whether short-term blockade of beta-adrenergic and COX-2 signaling during the perioperative window can alter the tumor microenvironment and systemic immune responses linked to metastatic spread.
Who should consider this trial
Good fit: Women aged 20–85 with suspected high-grade ovarian epithelial cancer who are scheduled for primary or interval debulking surgery and can give informed consent are the intended participants.
Not a fit: Patients already on chronic beta-blockers or COX inhibitors, those with active asthma or allergy to the study drugs, or those not undergoing debulking surgery are unlikely to benefit from this perioperative intervention.
Why it matters
Potential benefit: If successful, the approach could reduce metastatic spread and lower recurrence after surgery by limiting surgery-triggered tumor promotion and improving anti-tumor immunity.
How similar studies have performed: Preclinical studies and some small clinical reports in other cancers have suggested benefit from perioperative beta-blockade plus COX-2 inhibition, but robust evidence in ovarian cancer is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 20-85 * ASA score 1-3 or ECOG Performance Status of 0 to 2 * Patients with a suspected high-grade ovarian epithelial cancer based on imaging, clinical examination, CA125, and/or tumor biopsy * Patients planned for surgery for primary surgery, or interval debulking surgery for ovarian cancer * Signed informed consent form * Willing and able to comply with study procedures (physically and mentally) Exclusion Criteria: * Patients who participate in another interventional study * Patients with known allergy to one or more of the study medications, or to any medication from the non-steroidal anti-inflammatory drug group or beta-blockers family * Patients treated chronically with any type of a beta-adrenergic blocker or a COX inhibitor, except use of Aspirin, which will be discontinued at least 7 days prior to surgery, and until 3 weeks post-surgery * Patients currently suffering from asthma (אסתמה פעילה בלבד), or required hospital admission or change in medical treatment for asthma within the past year * Patients with active peptic disease * Patients with a history of CVA/TIA * Recent (within the last 5 years) or concurrent malignancies, with the exception of adequately treated in-situ carcinoma of the cervix or basal-cell carcinoma of the skin * Patients with renal failure, measured by creatinine level \>1.5 * Patients with significant liver dysfunction (known cirrhosis, Bilirubin level\>2) * Patients with significant heart failure (NYHA functional class 3 or Higher) * Patients with bradycardia (heart rate of 50 or less) or second- or third-degree AV block * Patients with right-sided heart failure owing to pulmonary hypertension * Patients with chronic Digoxin treatment * Patients with Printzmetal's angina * Patients with significant diagnosed cardiomegaly * Patients suffering from sick sinus syndrome * Patients with peripheral vascular disease * Patients with current (unresected) pheochromocytoma * Pregnant women * Patients who are treated with immunosuppressive medications, including chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug * Patients with Immunodeficiency Disorders
Where this trial is running
Ramat Gan and 1 other locations
- The Chaim Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Tel Aviv Sourasky Medical Center (Ichilov Hospital) — Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: Nadav Michaan, Prof. — Tel Aviv Sourasky Medical Center (Ichilov Hospital)
- Study coordinator: Shamgar Ben-Eliyahu, Prof.
- Email: shamgar@tauex.tau.ac.il
- Phone: 972-3-6407266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.