Advanced Cancers Clinical Trial
Official title:
A Double Blinded, Randomized Study Comparing the Effectiveness of Fish Oil Supplements, Oral Statins, and Placebo in Reducing the Incidence of Atrial Fibrillation Following a Lung Resection in Patients With Lung Cancer
Verified date | July 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The goal of this clinical research study is to learn if Lipitor (atorvastatin) or fish oil supplements can help to control side effects of the heart that are commonly seen after lung surgery (such as irregular heartbeat). Researchers also want to learn if one of these drugs is more effective than the other at controlling side effects.
Status | Terminated |
Enrollment | 2 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients need to be in a normal sinus rhythm preoperatively. 2. Participants undergoing planned lobectomy and 60 years of age or older or participants undergoing planned pneumonectomy and 18 years of age or older. 3. Planned procedure is 5 days after the start of taking study drugs. 4. Signed written informed consent 5. Women of childbearing potential must have a negative pregnancy test (A woman of childbearing potential is a women who has not been naturally postmenopausal for at least 12 consecutive months or who has not undergone previous surgical sterilization) 6. Adequate liver function evidenced by; aspartate aminotransferase (AST or SGOT) </= 2.5 * Upper Limits of Normal (ULN), and alanine aminotransferase (ALT or SGPT) </= 2.5 * ULN Exclusion Criteria: 1. Any history of supraventricular arrhythmia for which the patient is taking medications. 2. Current use of antiarrhythmic medications other than beta-receptor antagonists, calcium-channel antagonists, or digitalis. 3. Use of any supplemental n-3 fatty acids during the previous three months. 4. Use of any statin therapy during the previous three months. 5. Patients known to have a history of recent drug or alcohol abuse. 6. Known allergy to seafood 7. Current use of Gemfibrozil and Fenofibrate. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidences of Atrial Fibrillation During First 4 Days After Lung Resection | New onset of sustained (15 min or >) or clinically significant (requiring intervention) atrial fibrillation (AF) during first 4 days post surgery as defined by on American College of Cardiology and American Heart Association Physician Consortium. | Baseline to 4 days post surgery | No |
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