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

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

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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