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Search / Trial NCT06839144

Inhibiting Beta-adrenergic and COX-2 Signaling During the Perioperative Period to Reduce Ovarian Cancer Progression

Launched by TEL-AVIV SOURASKY MEDICAL CENTER · Feb 16, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Ovarian Cancer Perioperative Intervention Beta Blockers Propranolol Cox 2 Inhibitors Etodolac Psychoneuroimmunology Stress And Cancer Randomized Controlled Trial (Rct) Biomarker Analysis

ClinConnect Summary

This clinical trial is looking at how certain medications might help women with ovarian cancer during and after surgery. Specifically, it investigates whether using propranolol, a beta-blocker that affects the heart and stress response, along with etodolac, a pain reliever that reduces inflammation, can slow down cancer growth and improve the immune system's ability to fight the disease. The study aims to see if this combination is safe and beneficial for patients while they undergo surgery to remove tumors.

To be eligible for this trial, participants need to be women aged between 20 and 85 who have been diagnosed with high-grade ovarian cancer. They should be scheduled for surgery to remove the cancer and be able to provide informed consent. However, those with certain health issues—like serious heart problems, active asthma, or other significant medical conditions—won't be able to participate. If you join the study, you can expect close monitoring throughout the process, and you'll receive support to ensure you understand the study and what it involves. This trial is not yet recruiting participants, but it represents an important step in exploring new ways to help women facing ovarian cancer.

Gender

FEMALE

Eligibility criteria

  • 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

About Tel Aviv Sourasky Medical Center

Tel Aviv Sourasky Medical Center, a leading academic medical institution in Israel, is renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a multidisciplinary approach, the center integrates cutting-edge medical technology and evidence-based practices to enhance patient care and outcomes. Its robust infrastructure supports a diverse range of clinical studies, fostering collaboration among healthcare professionals, researchers, and industry partners. The center's dedication to research excellence and patient safety positions it as a key player in the global clinical research landscape, driving advancements in medical knowledge and treatment options.

Locations

Ramat Gan, , Israel

Tel Aviv, , Israel

Patients applied

0 patients applied

Trial Officials

Nadav Michaan, Prof.

Principal Investigator

Tel Aviv Sourasky Medical Center (Ichilov Hospital)

Anna Blecher, Dr.

Principal Investigator

The Chaim Sheba Medical Center (Tel Hashomer)

Shamgar Ben-Eliyahu, Prof.

Principal Investigator

Tel Aviv University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported