Skip to main content
OpenTrials
Completed

NCT Number: NCT03776149

Cardiovascular Function in Cancer Survivors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kansas State University - Clinical Integrative Physiology Laboratory

Manhattan, Kansas, 66506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Beetroot juice

Dietary Supplement

Following randomization on day 1, subjects will consume either the nitrate or nitrate-free beverage for 7 days with outcome measurements performed on day 7. Following a 7 day washout, subjects will then consume the crossover beverage for 7 days with outcome measures performed on day 21.

Black currant juice

Dietary Supplement

Following randomization on day 1, subjects will consume either the nitrate or nitrate-free beverage for 7 days with outcome measurements performed on day 7. Following a 7 day washout, subjects will then consume the crossover beverage for 7 days with outcome measures performed on day 21.

Primary outcomes

  1. Change in Left ventricular function

    Time frame: The change between day 1 and day 21

    Left ventricular function as measured by transthoracic echocardiography

Secondary outcomes

  1. Change in Vascular function

    Time frame: The change between day 1 and day 21

    Vascular function measured as changes in arterial stiffness and endothelial function.

  2. Change in Blood pressure

    Time frame: The change between day 1 and day 21

    Local limb blood pressure measured in millimeters of mercury (mmHg) following study interventions/arms

Sponsors and collaborators

Lead sponsor

Kansas State University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2018
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.