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Cardiovascular Function in Cancer Survivors

Sponsor
Kansas State University (Other)
Overall Status
Completed
CT.gov ID
NCT03776149
Collaborator
(none)
13
Enrollment
1
Location
2
Arms
24.7
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Beetroot juice
  • Dietary Supplement: Black currant juice
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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.
Masking:
Double (Participant, 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.
Primary Purpose:
Supportive Care
Official Title:
Therapeutic Role of Dietary Nitrates on Cardiovascular Function in Cancer Survivors Treated With Anthracycline Chemotherapy
Actual Study Start Date :
May 10, 2018
Actual Primary Completion Date :
May 31, 2020
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Dietary Supplement: 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.
Placebo Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Left ventricular function [The change between day 1 and day 21]

    Left ventricular function as measured by transthoracic echocardiography

Secondary Outcome Measures

  1. Change in Vascular function [The change between day 1 and day 21]

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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kansas State University - Clinical Integrative Physiology Laboratory Manhattan Kansas United States 66506

Sponsors and Collaborators

  • Kansas State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Carl Ade, M.S., Ph.D., Assistant Professor, Kansas State University
ClinicalTrials.gov Identifier:
NCT03776149
Other Study ID Numbers:
  • Pro9264
First Posted:
Dec 14, 2018
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 31, 2022