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Terminated due to low accrual.
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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.
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.
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Experimental | 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery. |
|
| Fish Oil Supplement | Experimental | 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery. |
|
| Placebo | Placebo Comparator | 4 capsules orally every morning and 3 every evening for 5 days pre-surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 1 capsule by mouth every morning 5 days before surgery, and 9 days after surgery or until discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ara Vaporciyan, MD, BS | UT MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| UT MD Anderson Cancer Center website | View source |
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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.
Recruitment Period: January 06, 2011 to July 29, 2011. All recruitment done at UT MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery. |
| FG001 | Fish Oil Supplement | 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. |
|
|
| 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. |
|
| FG002 | Placebo | 4 capsules orally every morning and 3 every evening for 5 days pre-surgery. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery. |
| BG001 | Fish Oil Supplement | 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery. |
| BG002 | Placebo | 4 capsules orally every morning and 3 every evening for 5 days pre-surgery. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | years |
| ||||||||||||||||||
| Gender | Number | participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was to be per protocol. There is no analysis due to an inadequate number of enrolled participants in study which resulted in early termination. | Posted | Baseline to 4 days post surgery |
|
|
9 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin | 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery. | 2 | 2 | 2 | 2 | ||
| EG001 | Fish Oil Supplement | 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery. | 0 | 0 | 0 | 0 | ||
| EG002 | Placebo | 4 capsules orally every morning and 3 every evening for 5 days pre-surgery. | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| decreased hemoglobin | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| hypotension | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ara Vaporciyan, MD, BS / Professor | UT MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D014565 | Urogenital Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005231 | Fatty Acids, Unsaturated |
| D005395 | Fish Oils |
| D009821 | Oils |
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| Title | Measurements |
|---|---|
|