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β-adrenergic Blocker and a COX2 Inhibitor for Prevention of Colorectal Cancer Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00888797
Recruitment Status : Unknown
Verified July 2011 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : April 28, 2009
Last Update Posted : July 12, 2011
Sponsor:
Collaborators:
Tel-Aviv Sourasky Medical Center
Rabin Medical Center
Information provided by:
Sheba Medical Center

Study Description
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Brief Summary:
Colon and rectal cancer is the second most prevalent malignant disease in the western world, causing significant morbidity, mortality, and healthcare sources use. Treating colon and rectal cancer with curative intent generally includes resection of the primary tumor. Despite its crucial role, surgery by itself induce physiological changes resulting in significant immune depression and other physiological perturbations, which may in turn play a significant role in the initiation of new metastases and the progression of pre-existing dormant metastases. The aim of this study is to assess the use of perioperative medical intervention using a combination of a β-adrenergic blocker (Propranolol) and a COX2 inhibitor (Etodolac), in order to attenuate the surgically induced immunosuppression and other physiological perturbations, aiming to reduce the rate of tumor recurrence and distant metastatic disease.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Propranolol and Etodolac Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Perioperative β-adrenergic Blocker and a COX2 Inhibitor in Patients Undergoing Resection for Primary Colon and Rectal Cancer: Effect on Tumor Recurrence and Postoperative Immune Perturbations. A Multicenter Randomized Prospective Trial.
Study Start Date : January 2010
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Perioperative Propranolol and Etodolac
 Drug: Propranolol and Etodolac
Both study medications will be given orally for an intervention phase of 20 days as follows: 5 days prior to surgery, on the day of surgery, and 14 days postoperatively. Etodolac:800 mg PO bid for the entire intervention period,Propranolol:20 mg PO bid for 5 preoperative days, 80 mg PO bid on the day of surgery, 40 mg PO bid for the first postoperative week, 20 mg PO bid for the second postoperative week.
Placebo Comparator: 2
Placebo
 Drug: Propranolol and Etodolac
Both study medications will be given orally for an intervention phase of 20 days as follows: 5 days prior to surgery, on the day of surgery, and 14 days postoperatively. Etodolac:800 mg PO bid for the entire intervention period,Propranolol:20 mg PO bid for 5 preoperative days, 80 mg PO bid on the day of surgery, 40 mg PO bid for the first postoperative week, 20 mg PO bid for the second postoperative week.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of recurrent and metastatic cancer [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. magnitude and duration of surgically induced immune depression, as reflected in the blood samples [ Time Frame: early postoperative ]
  2. Early postoperative morbidity and mortality [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients planned for surgery for primary resection of colon and rectal cancer in curative intent.
  • Single colonic or rectal carcinoma, proofed by full colonoscopy and tumor biopsy. If colonoscopy failed to reach the cecum, proximal colonic investigation will be made using contract enema or CT colonography.
  • No evidence of metastatic disease prior to surgery. Minimal workup would include abdominal CT with IV contrast (or CT+liver US) and chest XR.
  • Age between 18 and 75 year old.
  • ASA score of 1-3
  • The patient is able to understand the study objectives and procedures, able to comply with the protocol, and is capable to sign an informed consent.

Exclusion Criteria:

  • Patients with metastatic disease, known prior to surgery.
  • Patients in whom metastatic disease is found at surgery will complete the intervention phase, followed for additional month for potential complications, and will exit the study to allow potential participation in further clinical trials.
  • Patients in whom surgical resection is planned without curative intent.
  • Patients with renal failure, measured by Creatinine level >1.5
  • Patients with significant heart failure (NYH 3 or higher)
  • Patients with significant liver failure (known cirrhosis, Bilirubin level>2)
  • Patients suffering from asthma
  • Patients with known allergy to one or more of the study medications
  • Patients with known allergy to any medication from the non-steroidal anti-inflammatory drug group.
  • Patients with diabetes (type 1 or 2).
  • Patients treated chronically with one or more of the study medications
  • Patients treated chronically with any type of Beta adrenergic blocker.
  • Patients treated chronically with any type of COX inhibitor.
  • Patients with second or third degree AV block.
  • Patients with sinus bradycardia (patients with heart rate of less than 50).
  • Patients with sick sinus syndrome.
  • Patients with Prinzmetal's angina
  • Patients with right sided heart failure owing to pulmonary hypertension.
  • Patients with significant cardiomegaly
  • Patients with (current) pheochromocytoma
  • Patients with chronic Digoxin treatment
  • Patients with active peptic disease
  • Patients with peripheral vascular disease
  • Patients with history or concomitant malignant disease of any type.
  • 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.
  • Pregnant woman.
  • Patients participating in any other clinical trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888797


Contacts
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Contact: Oded Zmora, M.D. 972-3-5302247 ozmora@post.post.tau.ac.il

Locations
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Israel
Rabin- Beilinson Medical Center Not yet recruiting
Petah Tikva, Israel
Contact: Nir Wasserberg, M.D.       nirw@clalit.org.il   
Principal Investigator: Nir Wasserberg, M.D.         
Tel Aviv-Sourasky Medical Center Not yet recruiting
Tal Aviv, Israel
Contact: Hagit Tulchinsky, M.D.       hagitt@tasmc.health.gov.il   
Principal Investigator: Hagit Tulchinsky, M.D.         
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 45858
Contact: Oded Zmora, M.D.    972-3-5302247    ozmora@post.tau.ac.il   
Principal Investigator: Oded Zmora, M.D.         
Sub-Investigator: Marat Khaikin, M.D.         
Sponsors and Collaborators
Sheba Medical Center
Tel-Aviv Sourasky Medical Center
Rabin Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Oded Zmora, MD, Deparetment of Surgery, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00888797    
Other Study ID Numbers: SHEBA-09-6994-OZ-CTIL
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Colorectal Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Etodolac
 Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents