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.
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
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
Parallel
Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor)
Drug\- 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.
Placebo (Matching for Propranolol & Etodolac)
Drug\- Placebo Arm: Placebo (Matching for Propranolol \& Etodolac). Inert placebo tablets matching propranolol and etodolac in appearance and dosing schedule. Administration Route: Oral.
Transcriptional Activity in Excised Tumors
Transcriptional activity related to pro-metastatic (e.g., EMT), pro-growth (STAT and GATA families), and stress and inflammatory signaling (NF-κB/cRel, AP-1, CREB, GR) in excised tumors.
Transcriptional Activity in Blood Samples
Longitudinal analysis of transcriptional activity in peripheral blood, focusing on stress/inflammatory pathways (NF-κB/cRel, AP-1, CREB, GR). Unit of measure: Relative expression levels (fold change).
Adverse Event Assessment
Recording and categorization of adverse events, using a standardized tool (e.g., CTCAE-Common Terminology Criteria for Adverse Events) to assess the severity and type of adverse events. Unit of Measure: Number and severity of adverse events.
Patient Adherence to Drug Regimen
Patient adherence will be assessed using pill counts or patient self-reports. Unit of Measure: Percentage of prescribed dosage consumed.
Three-Year Recurrence Rate
Assessment of recurrence in patients based on medical records and follow-ups at 3 years post-surgery.
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Tel-Aviv Sourasky Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
The Chaim Sheba Medical Center
Collaborator
