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Inhibiting Beta-adrenergic and COX-2 Signaling During the Perioperative Period to Reduce Ovarian Cancer Progression
RECRUITINGPhase 2Sponsored by Tel-Aviv Sourasky Medical Center
Actively Recruiting
PhasePhase 2
SponsorTel-Aviv Sourasky Medical Center
Started2025-03-12
Est. completion2026-08-31
Eligibility
Age20 Years – 85 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06839144
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
Age: 20 Years – 85 YearsSex: FEMALEHealthy volunteers accepted
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
Conditions3
CancerOvarian CancerOvarian Cancer Metastatic Recurrent
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Actively Recruiting
PhasePhase 2
SponsorTel-Aviv Sourasky Medical Center
Started2025-03-12
Est. completion2026-08-31
Eligibility
Age20 Years – 85 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06839144