Cardiovascular Function in Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-10

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow and Cognitive Function

NCT05810974

Post Menopausal

COMPLETED NA

Dietary Nitrate and Healthy Older Adults

NCT03473678

Blood Pressure Cognitive Change Functional Capacity +1 more

COMPLETED NA

Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease

NCT03826147

Chronic Kidney Disease

UNKNOWN PHASE4

Nitrate, Exercise and Vascular Function in Midlife Women

NCT06527248

Healthy Menopause Hypertension +1 more

NOT_YET_RECRUITING NA

The Effects of Nitrate, Caffeine, and Cold Exposure on Cardiovascular Function.

NCT06602921

Nitrate Caffeine Cold Exposure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Survivor With History of Anthracycline Chemotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Beetroot juice (dietary nitrate)

Over 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.

Group Type EXPERIMENTAL

Beetroot juice

Intervention Type 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 (placebo control)

Over 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.

Group Type PLACEBO_COMPARATOR

Black currant juice

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beetroot 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.

Intervention Type DIETARY_SUPPLEMENT

Black 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No