Preventing colorectal cancer metastasis after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

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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 it's running

• Asaf Harofeh Medical Center
  Tsrifin, Israel Recruiting
• 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 HaShomer, Israel Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.