Reducing metastatic processes in pancreatic cancer patients undergoing surgery
Perioperative Use of a Beta-adrenergic Blocker and a COX-2 Inhibitor in Patients Undergoing Surgery With Primary Pancreatic Cancer: Intervention Aiming to Reduce Pro-metastatic Processes
This study tests whether a combination of two medications can help prevent cancer from spreading in patients with pancreatic cancer who are having surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Tel Hashomer and 2 other locations) |
| Trial ID | NCT03838029 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of propranolol, a beta-blocker, and etodolac, a COX-2 inhibitor, to reduce post-surgical metastatic disease in patients with resectable pancreatic cancer. The study focuses on the perioperative period, where stress and inflammatory responses can promote cancer progression. By targeting these responses, the trial aims to improve outcomes for patients undergoing curative surgery. Participants will be monitored for their response to the treatment compared to a placebo group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 80 with newly diagnosed Stage I or II resectable pancreatic adenocarcinoma.
Not a fit: Patients with metastatic disease, significant heart failure, or those who have had prior malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of metastatic disease in pancreatic cancer patients after surgery.
How similar studies have performed: While the approach of using beta-blockers and COX-2 inhibitors in this context is novel, animal studies have shown promising results in reducing cancer progression.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed Stage I or II adenocarcinoma of the head, neck, or uncinated- process of the pancreas. * Surgically resectable disease (R0 or R1) by spiral CT chest and abdomen scan, No distant metastases * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 * Signed informed consent form * Willing and able to comply with study procedures * Men and women from age 20 up to age 80 Exclusion Criteria: * Patients with metastatic disease, known prior to surgery * Patients with history or concomitant malignant disease of any type (except for the current pancreatic cancer * Patients who were treated with chemotherapy in the last 10 years for any reason * Patients in whom surgical resection is planned without curative intent * Patients exhibiting levels Carbohydrate antigen (CA) 19-9 above 500 * Patients with renal failure, measured by creatinine level \>1.5 * Patients with significant heart failure (NYHA functional class 3 or higher), * Patients with significant liver failure (known cirrhosis) * Patients suffering from active asthma * Patients with known allergy to any medication from the non-steroidal anti- inflammatory or beta-blockers drug group * Patients treated chronically with any type of a beta-adrenergic blocker or a cyclooxygenase (COX) inhibitor * Patients with bradycardia or second or third degree atrioventricular block (AV) block * Patients with a history of cerebrovascular accident (CVA) or established diagnosed transient ischemic attack (TIA) * Patients with prinzmetal's angina * Patients with right sided heart failure owing to pulmonary hypertension * Patients with significant diagnosed cardiomegaly * Patients with (current) pheochromocytoma * Patients with chronic Digoxin treatment * Patients with active peptic disease * Patients with peripheral vascular disease * Pregnant woman * Special population with impaired judgment * Patients currently actively participating in any other clinical trial * contraindication for Whipple procedure * Patients suffering from sick sinus syndrome * Patients with borderline resectable tumors, as defined by one of the following: * an infiltration \>180° of the portal vein * abutment of the tumor to the superior mesenteric artery * infiltration of the superior mesenteric artery or the celiac trunk
Where this trial is running
Tel Hashomer and 2 other locations
- Sheba Medical Center — Tel Hashomer, Israel (Recruiting)
- Sourasky Medical Center — Tel-Aviv, Israel (Not_yet_recruiting)
- Asaf Harofeh Medical Center — Tsrifin, Israel (Recruiting)
Study contacts
- Principal investigator: Oded Zmora, MD — Asaf Harofeh Medical Center
- Study coordinator: Oded Zmora, MD
- Email: ozmora@post.tau.ac.il
- Phone: +97289779202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.