Cardiovascular Function in Cancer Survivors

Not Applicable

Completed

• Conditions: Cancer Survivor With History of Anthracycline Chemotherapy

• Registration Number: NCT03776149
• Lead Sponsor: Kansas State University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-05-10
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-14
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Left ventricular function	The change between day 1 and day 21	Left ventricular function as measured by transthoracic echocardiography

Secondary Outcome Measures

Name	Time	Method
Change in Vascular function	The change between day 1 and day 21	Vascular function measured as changes in arterial stiffness and endothelial function.
Change in Blood pressure	The change between day 1 and day 21	Local limb blood pressure measured in millimeters of mercury (mmHg) following study interventions/arms

Trial Locations

Locations (1)

Kansas State University - Clinical Integrative Physiology Laboratory; 🇺🇸 Manhattan, Kansas, United States