Clincosm LogoSign in Get a demo

Rosuvastatin in Treating Women With Cardiovascular Complications Who Are Undergoing Chemotherapy For Breast Cancer

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Terminated
CT.gov ID
NCT01051401
Collaborator
National Cancer Institute (NCI) (NIH)
5
Enrollment
1
Location
2
Arms
48
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized pilot clinical trial studies rosuvastatin in treating women with cardiovascular complications who are undergoing chemotherapy for breast cancer. Rosuvastatin may prevent or lessen cardiovascular complications in patients undergoing chemotherapy for breast cancer

Condition or Disease Intervention/Treatment Phase
  • Drug: rosuvastatin
  • Other: placebo
  • Other: survey administration
  • Procedure: management of therapy complications
 Phase 1

Detailed Description

OBJECTIVES:
  1. Evaluate the feasibility of administering Rosuvastatin to breast cancer patients undergoing treatment with anthracyclines, paclitaxel, cyclophosphamide, and trastuzumab for breast cancer.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive rosuvastatin orally (PO) once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Arm II: Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Statin Therapy as a Protective Technique for Potential Cardiovascular Event Occurrences Among Breast Cancer Patients Undergoing Chemotherapy Treatment
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (rosuvastatin)

Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Drug: rosuvastatin
Given PO

Other: survey administration
Correlative study

Procedure: management of therapy complications
Other Names:
  • complications of therapy, management of

    		•
    Placebo Comparator: Arm II (placebo)

    Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.

    Other: placebo
    Given PO
    Other Names:
  • PLCB

    • Other: survey administration
    Correlative study

    Procedure: management of therapy complications
    Other Names:
  • complications of therapy, management of

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Whether the rate of statin adherence for patients taking chemotherapy is comparable to the rate of adherence found in prior studies (i.e., JUPITER study) [3 months]

    Secondary Outcome Measures

    1. Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc) [At baseline]

    2. Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc) [3 months]

    3. Rates of side-effects in the two groups [After 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Women receiving therapy for breast cancer without a history of cardiovascular disease An low-density lipoprotein (LDL) cholesterol level of less than 160 mg per deciliter (3.4 MMol per liter) Willingness to participate for the duration of the trial (3 months) Written informed consent Triglyceride level of less than 500 mg per deciliter (5.6 mmol per liter)

    Exclusion Criteria:

    Previous or current use of lipid-lowering therapy Current use of postmenopausal hormone-replacement therapy Evidence of hepatic dysfunction (an alanine aminotransferase level that was more than twice the upper limit of the normal range) Creatine kinase level that was more than three times the upper limit of the normal range Creatinine level that was higher than 2.0 mg per deciliter (176.8 umol per liter) Diabetes Uncontrolled hypertension (systolic blood pressure > 190 mm Hg or diastolic blood pressure > 100 mm Hg) Uncontrolled hypothyroidism (a thyroid-stimulating hormone level that was more than 1.5 times the upper limit of the normal range) Recent history of alcohol or drug abuse or another medical condition that might compromise safety or the successful completion of the study Exclude patients with inflammatory conditions such as severe arthritis, lupus, or inflammatory bowel disease, and patients taking immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids Pregnant women are excluded from participation in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: William Hundley, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01051401
    Other Study ID Numbers:
    • IRB00009933
    • NCI-2010-00125
    • CCCWFU 98509
    First Posted:
    Jan 18, 2010
    Last Update Posted:
    Aug 1, 2018
    Last Verified:
    Jul 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Aug 1, 2018