MedPath

Cardiovascular Function in Cancer Survivors

Not Applicable
Completed
Conditions
Cancer Survivor With History of Anthracycline Chemotherapy
Interventions
Dietary Supplement: Beetroot juice
Dietary Supplement: Black currant juice
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 β‰ˆ230,000 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.

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
Arm && Interventions
GroupInterventionDescription
Beetroot juice (dietary nitrate)Beetroot juiceOver the 7 days preceding each testing session, participants will consume 140 ml per day of beetroot juice (Beet It (HeartBeet Ltd.), Ipswich, UK). During this time participants will be asked to abstain from use of antiseptic mouthwash as this has been shown to temporarily kill the bacteria that facilitate the reduction of nitrate to nitrite. All participants will be asked to refrain from consuming any antioxidant (e.g., Vit E or Fish Oil) supplements during the course of the study as these may impact the study findings.
Black currant juice (placebo control)Black currant juiceOver the 7 days preceding each testing session, participants will consume 140 ml per day of a nitrate-depleted placebo. During this time participants will be asked to abstain from use of antiseptic mouthwash as this has been shown to temporarily kill the bacteria that facilitate the reduction of nitrate to nitrite. All participants will be asked to refrain from consuming any antioxidant (e.g., Vit E or Fish Oil) supplements during the course of the study as these may impact the study findings.
Primary Outcome Measures
NameTimeMethod
Change in Left ventricular functionThe change between day 1 and day 21

Left ventricular function as measured by transthoracic echocardiography

Secondary Outcome Measures
NameTimeMethod
Change in Vascular functionThe change between day 1 and day 21

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

Change in Blood pressureThe 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

πŸ‡ΊπŸ‡Έ

Manhattan, Kansas, United States

Β© Copyright 2025. All Rights Reserved by MedPath