Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor)Placebo (Matching for Propranolol & Etodolac)
Propranolol (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.
Placebo (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.
Study 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
FEMALE
Min age
20 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Transcriptional Activity in Excised Tumors — At the time of surgery (Day 0). Data will be reported through study completion, an average of 2 years. 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 — Preoperative baseline (Informed consent day), Day 0 (surgery), postoperative Day 1, Week 3, and Week 11. Data will be reported through study completion, an average of 2 years. 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 — From 5 days pre-surgery to 3 months post-surgery. 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 — From 5 days pre-surgery to 3 months post-surgery. Patient adherence will be assessed using pill counts or patient self-reports. Unit of Measure: Percentage of prescribed dosage consumed.
Recruitment Rate — Study duration (estimated 2 years). Number of participants enrolled in the study within the specified timeframe.
Trial sites (2)
Facility
City
Region
Status
The Chaim Sheba Medical Center
Ramat Gan
Israel
Recruiting
Tel Aviv Sourasky Medical Center (Ichilov Hospital)
Tel Aviv
Israel
Recruiting
More Tel-Aviv Sourasky Medical Center trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
