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临床试验/NCT03776149
NCT03776149已完成不适用

Therapeutic Role of Dietary Nitrates on Cardiovascular Function in Cancer Survivors Treated With Anthracycline Chemotherapy

Kansas State University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Change in Left ventricular function

研究概览

简要总结

The aim of the current project is to understand the effect of dietary nitrates (via beet-root juice), on its ability to improve parameters of cardiovascular health in cancer survivors with a history of anthracycline chemotherapy.

详细描述

Cancer remains one of the leading causes of death in modern society, but due in part to increasing rates of detection coupled with advanced therapies, of the ≈230,000 people newly diagnosed with breast cancer each year, approximately 90% are expected to live beyond 5 years. Despite the trend in improved cancer-related mortality, breast cancer survivors are at a significantly increased risk for cardiovascular disease (CVD) morbidity and mortality. As such the American Heart Association has recently highlighted the immediate need to evaluate changes in cardiovascular health and function in the early stages of cancer treatment.

The mechanisms of adjuvant therapies on cardiovascular function may be the result of increased generation of reactive oxygen species (ROS) and altered redox status, specifically the balance between nitric oxide and superoxide. As such, nitrate supplementation has been shown to attenuate Doxorubicin (chemotherapy drug)-induced ventricular function in animal models. These data implicate dietary nitrates as one potential therapeutic intervention that could be used to improve cardiovascular health in cancer survivors.

Beetroot juice (BRJ) is a nutritional supplement that has been studied to examine potential effects of dietary nitrates affecting vasodilation. The increased nitrate levels have been implicated in helping increase nitric oxide bioavailability, which have been shown to improve cardiovascular function in older adults and those with known cardiovascular disease. The question, however, of whether or not BRJ will enhance cardiovascular function in breast cancer survivors is yet to be determined.

The primary aim of the current investigation is to test the hypothesis that dietary nitrate supplementation, via beet-root juice, improves parameters of cardiovascular health in cancer survivors with a history of anthracycline chemotherapy treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

The supplement and placebo will be distributed to the individual by a member of the research team who is not involved with data collection or analysis.

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cancer survivors (at least 1 year post treatment)
  • Prior administration of anthracycline chemotherapy
  • partial/complete remission

排除标准

  • Unable to provide informed consent
  • Kidney disease
  • High risk of kidney stones
  • Diagnosed hemochromatosis
  • Pregnant, breast feeding, or planning to become pregnant
  • Non-English speaking

结局指标

主要结局

Change in Left ventricular function

时间窗: The change between day 1 and day 21

Left ventricular function as measured by transthoracic echocardiography

次要结局

  • Change in Vascular function(The change between day 1 and day 21)
  • Change in Blood pressure(The change between day 1 and day 21)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carl Ade, M.S., Ph.D.

Assistant Professor

Kansas State University

研究点 (2)

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