Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
2019年9月26日 更新者：Avera McKennan Hospital & University Health Center
A Phase II Pilot Study Using Metformin to Reduce Cardiac Toxicity in Breast Cancer Patients
The goal of this study is to determine if co-administration of metformin and doxorubicin in breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of patients who develop a significant change in left ventricle ejection fraction (LVEF).
研究概览
详细说明
This is a randomized, open-label, phase II design pilot study in patients with breast cancer requiring neoadjuvant or adjuvant chemotherapy.
Eligible patients will be equally randomized to either receive metformin plus standard of care therapy or standard of care therapy alone.
Patients receiving metformin will continue drug until the doxorubicin-containing cycles are complete, unless unacceptable toxicity occurs or the patient decides to withdraw from the study.
Both arms of the study will undergo echocardiograms with contrast at baseline, upon completion of doxorubicin-containing cycles (within 28 days of completion), and at the one-year and seven-year time points.
Additionally biomarker labs will be obtained to explore if there is a correlation between change in cardiac activity and the activity of metformin.
If willing, all enrolled patients will provide a sample of whole blood for further exploratory analysis.
Symptoms reported during the study will be correlated with know single nucleotide polymorphisms (SNPs) found during an exploratory genomic analysis.
研究类型
介入性
注册 (实际的)
30
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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South Dakota
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Sioux Falls、South Dakota、美国、57105
- Avera Cancer Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin
- Complete metabolic panel demonstrating adequate organ functions as defined by the following: Aspartate transaminase (AST) less than 2.5 times Upper Limit of Normal (ULN); Alanine transaminase (ALT) less than 2.5 times ULN; alkaline phosphatase less than 2.5 times ULN; serum creatinine less than 1.5 mg/dL; serum bilirubin less than ULN
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age greater than or equal to 21 years
Exclusion Criteria:
- Known diabetes
- History of cardiac arrhythmias or symptomatic cardiac disease
- Currently taking antiarrhythmic medications, beta-blockers, or other rate controlling cardiac medications
- Currently taking metformin and/or sulfonylureas
- Known hypersensitivity or intolerance to metformin
- Baseline ejection fraction of less than 50% measured by echocardiogram
- Known hypersensitivity to contrast used during echocardiogram
- Risk factors associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heard failure, history of acidosis, habitual intake of 3 or more alcoholic beverages per day)
- Pregnant or breast feeding
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Standard of Care
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
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Standard of care treatment with doxorubicin
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实验性的：Metformin + Standard of Care
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
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Standard of care treatment with doxorubicin
Metformin will begin to be administered prior to treatment with doxorubicin.
Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram
大体时间：1 year
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Determine whether the addition of metformin to standard doxorubicin therapy in breast cancer patients will decrease the incidence of change in left ventricle ejection fraction (LVEF).
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kirstin Williams, CNP、Avera McKennan Hospital & University Health Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年7月1日
初级完成 (实际的)
2018年5月23日
研究完成 (实际的)
2018年5月23日
研究注册日期
首次提交
2015年6月9日
首先提交符合 QC 标准的
2015年6月11日
首次发布 (估计)
2015年6月15日
研究记录更新
最后更新发布 (实际的)
2019年10月16日
上次提交的符合 QC 标准的更新
2019年9月26日
最后验证
2019年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Doxorubicin的临床试验
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National Cheng-Kung University HospitalNational Cheng Kung University; The Industrial Technology Research Institute完全的