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
Tel-Aviv Sourasky Medical Center
60 participants
Mar 12, 2025
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
Inclusion Criteria6
- 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 Criteria21
- 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
Interventions
\- 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 Arm: Placebo (Matching for Propranolol \& Etodolac). Inert placebo tablets matching propranolol and etodolac in appearance and dosing schedule. Administration Route: Oral.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06839144