Fish Oil Versus Statins Versus Placebos in Reducing Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers |
Drug: Atorvastatin Dietary Supplement: Fish Oil Supplement Other: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
- Incidences of Atrial Fibrillation During First 4 Days After Lung Resection [ Time Frame: Baseline to 4 days post surgery ] [ Designated as safety issue: No ]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.
| Enrollment: | 2 |
| Study Start Date: | January 2011 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Atorvastatin
1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
|
Drug: Atorvastatin
1 capsule by mouth every morning 5 days before surgery, and 9 days after surgery or until discharge.
Other Name: Lipitor
Other: Placebo
Placebo group: 4 capsules by mouth every morning and 3 every evening for 5 days before surgery and 9 days after surgery or until discharge. Atorvastatin group: 3 capsules by mouth every morning and evening, 5 days before surgery and 9 days after surgery or until discharge. Fish Oil Supplement group: 1 capsule by mouth every morning 5 days before surgery and 9 days after surgery or until discharge. |
|
Experimental: Fish Oil Supplement
3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
|
Dietary Supplement: Fish Oil Supplement
3 capsules by mouth in the morning and evening 5 days before surgery, and 9 days after surgery or until discharge.
Other Names:
Other: Placebo
Placebo group: 4 capsules by mouth every morning and 3 every evening for 5 days before surgery and 9 days after surgery or until discharge. Atorvastatin group: 3 capsules by mouth every morning and evening, 5 days before surgery and 9 days after surgery or until discharge. Fish Oil Supplement group: 1 capsule by mouth every morning 5 days before surgery and 9 days after surgery or until discharge. |
|
Placebo Comparator: Placebo
4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
|
Other: Placebo
Placebo group: 4 capsules by mouth every morning and 3 every evening for 5 days before surgery and 9 days after surgery or until discharge. Atorvastatin group: 3 capsules by mouth every morning and evening, 5 days before surgery and 9 days after surgery or until discharge. Fish Oil Supplement group: 1 capsule by mouth every morning 5 days before surgery and 9 days after surgery or until discharge. |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients need to be in a normal sinus rhythm preoperatively.
- Participants undergoing planned lobectomy and 60 years of age or older or participants undergoing planned pneumonectomy and 18 years of age or older.
- Planned procedure is 5 days after the start of taking study drugs.
- Signed written informed consent
- 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)
- 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:
- Any history of supraventricular arrhythmia for which the patient is taking medications.
- Current use of antiarrhythmic medications other than beta-receptor antagonists, calcium-channel antagonists, or digitalis.
- Use of any supplemental n-3 fatty acids during the previous three months.
- Use of any statin therapy during the previous three months.
- Patients known to have a history of recent drug or alcohol abuse.
- Known allergy to seafood
- Current use of Gemfibrozil and Fenofibrate.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Ara Vaporciyan, MD, BS | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01259284 History of Changes |
| Other Study ID Numbers: | 2009-0591 |
| Study First Received: | December 10, 2010 |
| Results First Received: | April 24, 2012 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Breast cancer Colorectal cancer Genitourinary cancer Head and neck cancers Lung cancer Melanoma |
Sarcoma Atorvastatin Lipitor Fish Oil supplement Placebo |
Additional relevant MeSH terms:
|
Atrial Fibrillation Lung Neoplasms Neoplasms Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013