Inhibiting Beta-adrenergic and COX-2 Signaling During the Perioperative Period to Reduce Ovarian Cancer Progression
NCT06839144 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-07-11
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.
Conditions
- Ovarian Cancer
- Ovarian Cancer Metastatic Recurrent
Interventions
- DRUG
-
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.
- DRUG
-
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.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
The Chaim Sheba Medical Center
collaborator OTHER -
Tel-Aviv Sourasky Medical Center
lead OTHER_GOV
Principal Investigators
-
Nadav Michaan, Prof. · Tel Aviv Sourasky Medical Center (Ichilov Hospital)
-
Anna Blecher, Dr. · The Chaim Sheba Medical Center (Tel Hashomer)
-
Shamgar Ben-Eliyahu, Prof. · Tel Aviv University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 85 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-12
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- Israel
Study Locations
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