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

NCT01259284 | Terminated Phase 2 Results DMC

• 1 other identifier: 2009-0591
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancers

Keywords

Breast cancer; Colorectal cancer; Genitourinary cancer; Head and neck cancers; Lung cancer; Melanoma; Sarcoma; Atorvastatin; Lipitor; Fish Oil supplement; Placebo

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Atorvastatin

EXPERIMENTAL

1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.

Drug: Atorvastatin; Other: Placebo

Fish Oil Supplement

EXPERIMENTAL

3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.

Dietary Supplement: Fish Oil Supplement; Other: Placebo

Placebo

PLACEBO COMPARATOR

4 capsules orally every morning and 3 every evening for 5 days pre-surgery.

Other: Placebo

Interventions

Atorvastatin DRUG

1 capsule by mouth every morning 5 days before surgery, and 9 days after surgery or until discharge.

Also known as: Lipitor

Atorvastatin

Fish Oil Supplement DIETARY_SUPPLEMENT

3 capsules by mouth in the morning and evening 5 days before surgery, and 9 days after surgery or until discharge.

Also known as: n-3 PUFA, Fish oil supplementation

Fish Oil Supplement

Placebo OTHER

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.

Atorvastatin; Fish Oil Supplement; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Urogenital Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Melanoma; Sarcoma

Interventions

Atorvastatin; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fish Oils; Oils

Results Point of Contact

• Title: Ara Vaporciyan, MD, BS / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Ara Vaporciyan, MD, BS

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 14, 2010
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 7, 2012
• Results First Posted: August 1, 2012

Record last verified: 2012-07

Locations

US (1)