Effect of Exercise Preconditioning in Ovarian Cancer on Treatment-Related Cardiotoxicity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- VO2 Peak
研究概览
简要总结
The purpose of this study is to determine if exercise preconditioning can mitigate the off target effects of chemotherapy treatment on measures of cardiovascular function, peripheral neuropathy, and quality of life.
详细描述
While survivorship for those diagnosed with epithelial ovarian cancer has continued to improve, the significant off target effects of adjuvant and neoadjuvant chemotherapy have become more prominent. These off-target effects include increased risk of cardiovascular disease, neuropathy, and decreased quality of life. Exercise initiated prior to chemotherapy induction and continued through treatment has promise in terms of preserving VO2peak and potentially mitigating the negative cardiovascular and neuropathic effects of chemotherapy. The goal of this study is to examine the effects of initiating exercise prior to any oncologic therapy and sustaining this exercise paradigm in newly diagnosed women with ovarian cancer who are undergoing initial surgery and chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention (i.e. exercise training), participants and study team members cannot be blinded. However, outcomes assessment will be carried out in a blinded fashion.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over
- •Presumed diagnosis of ovarian cancer and a planned chemotherapy regimen of a taxane and carboplatin with or without VEGF inhibition
- •Physician clearance for exercise training
排除标准
- •Any patient unable/unwilling to cooperate with all study protocols
- •Cancer recurrence
- •Previous treatment with chemotherapy in the last 5-years
- •Medical/orthopedic co-morbidities that preclude exercise training
- •Significant heart, liver, kidney, blood, or respiratory disease precluding exercise participation
- •Peripheral vascular disease
- •Acute infectious disease or history of chronic infections
结局指标
主要结局
VO2 Peak
时间窗: 22 weeks
Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy
次要结局
- Brachial Artery Endothelium-Dependent Flow-Mediated Dilation(22 weeks)
- Diastolic Function(22 weeks)
- Ejection Fraction(22 weeks)
- Peripheral Neuropathy as assessed by the FACT-GOG-NTX Questionnaire(22 weeks)
- Carotid-Femoral Pulse Wave Velocity(22 weeks)
- Blood pressure(22 weeks)
- Peripheral Neuropathy(22 weeks)
- Health Related Quality of Life as Measured by the FACT-O Questionnaire(22 weeks)
- Quality of Life as Assessed by the Short Form Health Survey (SF-36)(22 weeks)
- Global Longitudinal Strain(22 weeks)
研究者
Siddartha Angadi
Assistant Professor
University of Virginia