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

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

Baseline Characteristics

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 ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

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
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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