Clinical trial · Interventional
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
NCT06839144CI-TRIAL-00092039OC-POP-PTrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer Metastatic Recurrent | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo (Matching for Propranolol & Etodolac) | Drug | — | UNRESOLVED |
| Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Patients receive propranolol + etodolac (active treatment)
- interventionNames
- Drug: Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Arm
- description
- Patients receive matching placebo for both drugs
- interventionNames
- Drug: Placebo (Matching for Propranolol & Etodolac)
Primary outcomes (5)
- measure
- Transcriptional Activity in Excised Tumors
- timeFrame
- At the time of surgery (Day 0). Data will be reported through study completion, an average of 2 years.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDShaashua L, Shabat-Simon M, Haldar R, Matzner P, Zmora O, Shabtai M, Sharon E, Allweis T, Barshack I, Hayman L, Arevalo J, Ma J, Horowitz M, Cole S, Ben-Eliyahu S. Perioperative COX-2 and beta-Adrenergic Blockade Improves Metastatic Biomarkers in Breast Cancer Patients in a Phase-II Randomized Trial. Clin Cancer Res. 2017 Aug 15;23(16):4651-4661. doi: 10.1158/1078-0432.CCR-17-0152. Epub 2017 May 10. PMID 28490464
- BACKGROUNDHaldar R, Ricon-Becker I, Radin A, Gutman M, Cole SW, Zmora O, Ben-Eliyahu S. Perioperative COX2 and beta-adrenergic blockade improves biomarkers of tumor metastasis, immunity, and inflammation in colorectal cancer: A randomized controlled trial. Cancer. 2020 Sep 1;126(17):3991-4001. doi: 10.1002/cncr.32950. Epub 2020 Jun 13. PMID 32533792
- BACKGROUNDHaldar R, Shaashua L, Lavon H, Lyons YA, Zmora O, Sharon E, Birnbaum Y, Allweis T, Sood AK, Barshack I, Cole S, Ben-Eliyahu S. Perioperative inhibition of beta-adrenergic and COX2 signaling in a clinical trial in breast cancer patients improves tumor Ki-67 expression, serum cytokine levels, and PBMCs transcriptome. Brain Behav Immun. 2018 Oct;73:294-309. doi: 10.1016/j.bbi.2018.05.014. Epub 2018 May 22. PMID 29800703