Statin Therapy as a Protective Technique for Potential Cardiovascular Event Occurrences Among Breast Cancer Patients Undergoing Chemotherapy Treatment
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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
详细描述
OBJECTIVES:
I. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Arm I (rosuvastatin)
Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: rosuvastatin (Drug)
Arm I (rosuvastatin)
Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: survey administration (Other)
Arm I (rosuvastatin)
Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: management of therapy complications (Procedure)
Arm II (placebo)
Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Other)
Arm II (placebo)
Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: survey administration (Other)
Arm II (placebo)
Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: management of therapy complications (Procedure)
结局指标
主要结局
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)
时间窗: 3 months
次要结局
- Rates of side-effects in the two groups(After 3 months)
- Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc)(3 months)