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
Results First Received: April 24, 2012  
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
Condition: Advanced Cancers
Interventions: Drug: Atorvastatin
Dietary Supplement: Fish Oil Supplement
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: January 06, 2011 to July 29, 2011. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was terminated with only 2 participants enrolled. The inability to find participants was predominantly due to current or recent use of statins or fish oils.

Reporting Groups
  Description
Atorvastatin 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
Fish Oil Supplement 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
Placebo 4 capsules orally every morning and 3 every evening for 5 days pre-surgery.

Participant Flow:   Overall Study
    Atorvastatin     Fish Oil Supplement     Placebo  
STARTED     2     0     0  
COMPLETED     0     0     0  
NOT COMPLETED     2     0     0  
Study Termination                 2                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atorvastatin 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
Fish Oil Supplement 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
Placebo 4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
Total Total of all reporting groups

Baseline Measures
    Atorvastatin     Fish Oil Supplement     Placebo     Total  
Number of Participants  
[units: participants]
  2     0     0     2  
Age  
[units: years]
Mean ( Full Range )
  69  
  ( 68 to 70 )  
   
   
   
   
  69  
  ( 68 to 70 )  
Gender  
[units: participants]
       
Female     2             2  
Male     0             0  
Region of Enrollment  
[units: participants]
       
United States     2             2  



  Outcome Measures

1.  Primary:   Incidences of Atrial Fibrillation During First 4 Days After Lung Resection   [ Time Frame: Baseline to 4 days post surgery ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Ara Vaporciyan, MD, BS / Professor
Organization: UT MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


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