Preventing colorectal cancer metastasis after surgery
Perioperative Use of a β-adrenergic Blocker, Propranolol, and a COX2 Inhibitor, Etodolac, in Patients Undergoing Resection With Curative Intent for Primary Colon and Rectal Cancer: Effect on Tumor Recurrence and Survival
This study is testing whether a combination of two medications, propranolol and etodolac, can help prevent the spread of colorectal cancer after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Afula and 5 other locations) |
| Trial ID | NCT03919461 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the combined use of propranolol, a beta-blocker, and etodolac, a COX-2 inhibitor, to prevent metastatic development in patients undergoing surgery for colorectal cancer. The study focuses on the perioperative period, which is marked by stress-induced inflammatory responses that may promote cancer progression. Previous animal studies have shown that the combination of these two medications can effectively reduce the risk of metastasis, and this trial aims to evaluate their safety and efficacy in human subjects. Patients will be monitored for outcomes related to cancer metastasis following their surgical procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 80 scheduled for curative surgery for primary colon or rectal cancer without evidence of metastatic disease.
Not a fit: Patients with known metastatic disease or those undergoing surgery without curative intent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of colorectal cancer metastasis after surgery, improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results with similar approaches in animal models, but this specific combination in humans is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Patients planned for surgery for primary resection of colon or rectal cancer with curative intent. 2. Single colonic or rectal carcinoma, proven by full colonoscopy and tumor biopsy. 3. No evidence of metastatic disease prior to surgery. Minimal workup would include abdominal CT with IV contrast (or CT+liver US) and chest XR. 4. ASA score of 1-3 or ECOG Performance Status of 0 to 1 5. Signed informed consent form 6. Willing and able to comply with study procedures (physically and mentally) 7. Men and women from age 20 to age 80 \- Exclusion Criteria: 1. Patients with metastatic disease, known prior to surgery 2. Patients in whom surgical resection is planned without curative intent 3. Patients with renal failure, measured by creatinine level \>1.5 4. Patients with significant heart failure (NYHA functional class 3 or higher) 5. Patients with significant liver failure (known cirrhosis, Bilirubin level\>2) 6. Patients currently suffering from asthma or Chronic Obstructive Pulmonary Disease (COPD) 7. Patients treated pharmacologically for diabetes mellitus (type 1/2), 8. Patients with peripheral vascular disease 9. Patients with known allergy to one or more of the study medications. 10. Patients with known allergy to any medication from the non-steroidal anti- inflammatory drug group or beta-blockers family 11. Patients treated chronically with any type of a beta-adrenergic blocker or a COX inhibitor 12. Patients with bradycardia or second or third degree AV block 13. Patients with a history of CVA/TIA 14. Patients with Printzmetal's angina 15. Patients with right sided heart failure owing to pulmonary hypertension 16. Patients with significant diagnosed cardiomegaly 17. Patients with (current) pheochromocytoma 18. Patients with chronic Digoxin treatment 19. Patients with active peptic disease 20. Pregnant women 21. Patients who participate in another interventional study 22. Patients with history or concomitant malignant disease of any type (except for the current colon/rectal cancer) 23. Patients who were treated with chemotherapy in the last 10 years for any reason besides neo-adjuvant therapy for rectal cancer within the last six months. 24. Patients who are treated with immunosuppressive medications 25. Patients with Immunodeficiency Disorders, or autoimmune disease treated by immunosuppressive medications. 26. Patients suffering from sick sinus syndrome
Where this trial is running
Afula and 5 other locations
- HaEmek Medical Center — Afula, Israel (Not_yet_recruiting)
- Rambam Health Care Campus — Haifa, Israel (Not_yet_recruiting)
- Rabin Medical Center — Petah Tikva, Israel (Not_yet_recruiting)
- Sourasky Medical Center — Tel Aviv, Israel (Not_yet_recruiting)
- Sheba Medical Center — Tel Litwinsky, Israel (Not_yet_recruiting)
- Asaf Harofeh Medical Center — Ẕerifin, 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.