Advanced CancersPhase 2/3NCT01259284
Fish Oil Versus Statins Versus Placebos in Reducing Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
A Phase 2/3 study testing Atorvastatin and Fish Oil Supplement in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Atorvastatin and Fish Oil Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read the detailed description
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.
- Conditions
- Advanced Cancers
- Being tested
- Atorvastatin, Fish Oil Supplement, Placebo
- Keywords
- Breast cancer, Colorectal cancer, Genitourinary cancer, Head and neck cancers, Lung cancer, Melanoma, Sarcoma, Atorvastatin, Lipitor, Fish Oil supplement, Placebo
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Urogenital Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Melanoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
1 capsule by mouth every morning 5 days before surgery, and 9 days after surgery or until discharge.
Fish Oil SupplementDietary supplement
Also called n-3 PUFA, Fish oil supplementation
3 capsules by mouth in the morning and evening 5 days before surgery, and 9 days after surgery or until discharge.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery. Receives: 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. Receives: Dietary Supplement: Fish Oil Supplement; Other: Placebo |
| Placebo | Placebo comparator | 4 capsules orally every morning and 3 every evening for 5 days pre-surgery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Terminated due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ara Vaporciyan, MD, BS, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259284
- Sponsor's protocol ID
- 2009-0591
- Status last verified
- Jul 2012
- First submitted
- 10 Dec 2010
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01259284
- Acronym / sponsor ID
- 2009-0591
- Conditions
- Advanced Cancers
- Keywords
- Breast cancer, Colorectal cancer, Genitourinary cancer, Head and neck cancers, Lung cancer, Melanoma, Sarcoma, Atorvastatin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Posted 1 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin, Other: Placebo1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery. |
| Fish Oil Supplement | Experimental | Dietary Supplement: Fish Oil Supplement, Other: Placebo3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery. |
| Placebo | Placebo comparator | Other: Placebo4 capsules orally every morning and 3 every evening for 5 days pre-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor1 capsule by mouth every morning 5 days before surgery, and 9 days after surgery or until discharge. | Drug | Atorvastatin |
| Fish Oil SupplementAlso: n-3 PUFA, Fish oil supplementation3 capsules by mouth in the morning and evening 5 days before surgery, and 9 days after surgery or until discharge. | Dietary supplement | Fish Oil Supplement |
| PlaceboPlacebo 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. | Other | Atorvastatin, Fish Oil Supplement, Placebo |
Primary outcome
Incidences of Atrial Fibrillation During First 4 Days After Lung Resection
Time frame: Baseline to 4 days post surgery
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Advanced Cancers
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ara Vaporciyan, MD, BS principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atorvastatin and Fish Oil Supplement in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of Atrial Fibrillation During First 4 Days After Lung Resection (time frame: Baseline to 4 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.