Cancer Survivor With History of Anthracycline Chemotherapy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBeetroot juice
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.
DIETARY_SUPPLEMENTBlack currant juice
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.
Sponsors
Kansas State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
This study utilizes a 7-day randomized, double-blind, placebo-controlled crossover study design, in which individuals are initially supplemented with a nitrate-rich supplement in the form of a specifically formulated beetroot juice, or nitrate-poor placebo. Individuals will then entered a 7-day washout period before entering the opposing arm of the study.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left ventricular function | The change between day 1 and day 21 | Left ventricular function as measured by transthoracic echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed