RecruitingPhase 2NCT06839144

Inhibiting Beta-adrenergic and COX-2 Signaling During the Perioperative Period to Reduce Ovarian Cancer Progression

Inhibiting Beta-adrenergic and COX-2 Signaling During the Perioperative Period to Reduce Ovarian Cancer Progression: A Randomized Placebo-Controlled Clinical Trial


Sponsor

Tel-Aviv Sourasky Medical Center

Enrollment

60 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study investigates the impact of perioperative inhibition of beta-adrenergic and COX-2 signaling in ovarian cancer patients undergoing debulking surgery. The trial aims to assess the feasibility, safety, and biological effects of a combination of propranolol and etodolac in reducing cancer metastasis and improving immune responses.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking two common medications — a beta-blocker (propranolol) and a COX-2 inhibitor (like ibuprofen) — around the time of surgery for ovarian cancer can reduce the spread of cancer cells and improve outcomes. Stress hormones released during surgery may help cancer spread, and these drugs may block that effect. **You may be eligible if...** - You are between 20 and 85 years old - You have suspected high-grade ovarian cancer based on scans, blood tests, or biopsy - You are scheduled for primary surgery or interval debulking surgery for ovarian cancer - Your general health score (ASA) is 1–3 or ECOG 0–2 **You may NOT be eligible if...** - You are allergic to beta-blockers or NSAIDs (anti-inflammatory drugs) - You are already regularly taking beta-blockers or COX inhibitors (aspirin is okay) - You have certain heart conditions that make beta-blockers unsafe - You are participating in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor)

\- Intervention Arm: Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor). Name: Propranolol (slow-Release) and Etodolac. Propranolol Dosage Schedule: 5 days pre-surgery: 20mg twice daily (BID), Day of surgery: 80mg BID, 1-week Post-surgery: 40mg BID, week 2-11 post-surgery: 20mg BID. Etodolac Dosage Schedule: 5 days pre-surgery until 3 weeks post-surgery: 400mg BID. Administration Route: Oral.

DRUGPlacebo (Matching for Propranolol & Etodolac)

\- Placebo Arm: Placebo (Matching for Propranolol \& Etodolac). Inert placebo tablets matching propranolol and etodolac in appearance and dosing schedule. Administration Route: Oral.


Locations(2)

The Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center (Ichilov Hospital)

Tel Aviv, Israel

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NCT06839144


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