Know Cancer

or
forgot password

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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Advanced Cancers

Thank you

Trial Information

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


The Study Drugs:

Atorvastatin is designed to lower cholesterol by blocking its production in the liver. This
may help to decrease the chances of having a heart attack or a stroke.

Fish oil supplements are designed to lower fat levels in the blood by blocking their
production in the liver. This may help to decrease the chances of having a heart attack or
a stroke.

Atorvastatin is FDA-approved and commercially available for lowering cholesterol or fat
levels in the blood. Fish oil supplements are also commercially available.

Researchers want to compare the anti-inflammatory effects of Atorvastatin and fish oil
supplements.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study
"Part" based on when you join this study. Up to 132 participants will be enrolled in Part
1 of the study. Up to 120 participants will be enrolled in Part 2 of the study.

If you are enrolled in Part 1, you will be randomly assigned (as in a roll of dice) to 1 of
3 groups. You will be provided with enough unmarked capsules for fourteen days plus a test
dose. You will take the test dose in the clinic in the presence of the research nurse.
Beginning 5 days before lung surgery (Day -5), you will take 1 capsule in the morning, as
well as 3 capsules 2 time each day (a total of 7 unmarked capsules each day) for 5 days.
The capsules should be taken with a cup (8 ounces) of water and may be taken with or without
food. You will be reminded by the research nurse to bring the remaining capsules from home
prior to your admission for surgery.

- If you are in Group 1, the capsules you will take will be fish oil supplements and
placebo. A placebo is a substance that looks like the study drug but has no active
ingredients.

- If you are in Group 2, the capsules you will take will be atorvastatin and placebo.

- If you are in Group 3, the capsules you will take will be placebo only.

You will have an equal chance of being assigned to each group. Neither you nor the study
staff will know if you are receiving the study drug or the placebo. However, if needed for
your safety, the study staff will be able to find out what you are receiving.

After Part 1 is complete, the groups will be compared to learn if any group was more
effective than the others. If neither fish oil supplements nor atorvastatin is shown to be
more effective than the placebo, the study will be stopped. If fish oil or atorvastatin is
found to be more effective than the placebo, the study will continue to Part 2.

If you are enrolled in Part 2, you will be randomly assigned to 1 of 2 study groups. You
will be provided with enough unmarked capsules for fourteen days plus a test dose. You will
take the test dose in the clinic in the presence of the research nurse, and begin taking
capsules 5 days before surgery (Day -5) for 5 days. If atorvastatin was found to be the more
effective drug in Part 1, you will take 1 unmarked capsule in the morning each day. If fish
oil was found to be the more effective drug in Part 1, you will take 3 capsules 2 times each
day (a total of 6 unmarked capsules each day). The capsules should be taken with a cup (8
ounces) of water and may be taken with or without food.

You will be reminded by the research nurse to bring the remaining capsules from home prior
to admission for surgery.

- If you are in Group 1, the capsules you will take will be the drug that was found to be
more effective in Part 1 (either fish oil supplements or atorvastatin).

- If you are in Group 2, the capsules you will take will be placebo only.

You will have an equal chance of being assigned to each group. Neither you nor the study
staff will know if you are receiving the study drug or the placebo. However, if needed for
your safety, the study staff will be able to find out what you are receiving.

Surgery:

After you have taken the study drug/placebo for 5 days, you will have standard of care lung
surgery performed. You will be given a separate consent form to read and sign for the
surgery.

On the day of surgery, any unused capsules will be collected and the days, times, and
reasons why any doses were missed will be recorded. You will then continue taking the study
drug/placebo for up to 9 days after surgery or until you are released from the hospital
(whichever comes first). You will follow the same dosing schedule you followed before
surgery.

Study Visits:

Each day while you are in the hospital, your vital signs will be measured and you will be
checked for any allergic reaction you may have had to the study drug/placebo.

On Days 1 and 3, and on the last day that you take the study drug/placebo, blood (about 1
teaspoon) will be drawn to check your liver function.

About 4-6 weeks after surgery, you will have a follow-up visit. At this visit, the
following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs.

- You will be asked about any symptoms and/or side effects you may have had.

- Blood (about 1 teaspoon) will be drawn to check your liver function.

Length of Study:

You will take the study drug/placebo for 5 days before surgery, and for up to 9 days after
surgery (up to a total of 14 days). Your participation in the study will be over after the
follow-up visit. You will be taken off study early if you have intolerable side effects
(such as allergic reaction or abnormal liver function tests).

This is an investigational study.

Up to 252 participants will take part in this study. All will be enrolled at M. D.
Anderson.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Incidences of Atrial Fibrillation During First 4 Days After Lung Resection

Outcome Description:

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.

Outcome Time Frame:

Baseline to 4 days post surgery

Safety Issue:

No

Principal Investigator

Ara Vaporciyan, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0591

NCT ID:

NCT01259284

Start Date:

January 2011

Completion Date:

September 2011

Related Keywords:

  • Advanced Cancers
  • Breast cancer
  • Colorectal cancer
  • Genitourinary cancer
  • Head and neck cancers
  • Lung cancer
  • Melanoma
  • Sarcoma
  • Atorvastatin
  • Lipitor
  • Fish Oil supplement
  • Placebo
  • Atrial Fibrillation
  • Lung Neoplasms
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030