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Clinical Trial Alliance A221501

Title
Preventing Anthracycline Cardiovascular Toxicity with Statins (PREVENT)
Principal Investigator
Daniel Lee
Details
  • Status: Accepting New Patients
  • Study Type: Supportive Care, Symptom Management
  • Protocol No:.Alliance A221501
Purpose
The purpose of this research study is to see if Atorvastatin (generic for Lipitor) 40 mg by mouth daily decreases the chance of developing heart problems in participants receiving anthracycline based chemotherapy for breast cancer or lymphoma.
Overview
Atorvastatin has been approved by the US Food and Drug Administration (FDA), but it has not been approved to lessen the chance of heart problems related to chemotherapy. In this study Atorvastatin will be compared to placebo. A placebo is a substance, like a sugar pill, that does not have any effect on your disease or condition. In this study participants will either receive the active study medication (Atorvastatin) or placebo, which is not active. Placebos are used in research studies to see if the drug being studied really does have an effect. This study will also include questions related to thinking process and quality of life.
Eligibility
Some of the eligibility criteria include:
  • Participants must be 21 years of age or older.
  • Recently diagnosed with breast cancer or lymphoma
  • Treatment plan includes chemotherapy
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants will be randomized to receive Atorvastatin or Placebo. Randomization means that participants are put into a group by chance. It is like flipping a coin. You will have an equal chance of being placed in any group. Atorvastatin and Placebo will be taken by mouth daily during chemotherapy. The questionnaires and the Memory and Thinking Ability Testing will take about 10 minutes at baseline and 30 minutes at 6 and 24 months to complete.
Contact
Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 19-Oct-17 07:36 AM

 

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