Blocking stress and inflammation around surgery to slow ovarian cancer spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.