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Fish Oil Versus Statins Versus Placebos in Reducing Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer

This study has been terminated.
(Terminated due to low accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01259284
First received: December 10, 2010
Last updated: July 31, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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:
  • n-3 PUFA
  • Fish oil supplementation
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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259284

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Neoplasms
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014