- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03776149
Cardiovascular Function in Cancer Survivors
Therapeutic Role of Dietary Nitrates on Cardiovascular Function in Cancer Survivors Treated With Anthracycline Chemotherapy
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Manhattan, Kansas, United States, 66506
- Kansas State University - Clinical Integrative Physiology Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Left ventricular function
Time Frame: The change between day 1 and day 21
|
Left ventricular function as measured by transthoracic echocardiography
|
The change between day 1 and day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vascular function
Time Frame: The change between day 1 and day 21
|
Vascular function measured as changes in arterial stiffness and endothelial function.
|
The change between day 1 and day 21
|
Change in Blood pressure
Time Frame: The change between day 1 and day 21
|
Local limb blood pressure measured in millimeters of mercury (mmHg) following study interventions/arms
|
The change between day 1 and day 21
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Patnaik JL, Byers T, DiGuiseppi C, Dabelea D, Denberg TD. Cardiovascular disease competes with breast cancer as the leading cause of death for older females diagnosed with breast cancer: a retrospective cohort study. Breast Cancer Res. 2011 Jun 20;13(3):R64. doi: 10.1186/bcr2901.
- Mulrooney DA, Blaes AH, Duprez D. Vascular injury in cancer survivors. J Cardiovasc Transl Res. 2012 Jun;5(3):287-95. doi: 10.1007/s12265-012-9358-7. Epub 2012 Mar 29.
- Chaosuwannakit N, D'Agostino R Jr, Hamilton CA, Lane KS, Ntim WO, Lawrence J, Melin SA, Ellis LR, Torti FM, Little WC, Hundley WG. Aortic stiffness increases upon receipt of anthracycline chemotherapy. J Clin Oncol. 2010 Jan 1;28(1):166-72. doi: 10.1200/JCO.2009.23.8527. Epub 2009 Nov 9.
- Duquaine D, Hirsch GA, Chakrabarti A, Han Z, Kehrer C, Brook R, Joseph J, Schott A, Kalyanaraman B, Vasquez-Vivar J, Rajagopalan S. Rapid-onset endothelial dysfunction with adriamycin: evidence for a dysfunctional nitric oxide synthase. Vasc Med. 2003 May;8(2):101-7. doi: 10.1191/1358863x03vm476oa.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro9264
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer Survivor With History of Anthracycline Chemotherapy
-
Kissei Pharmaceutical Co., Ltd.CompletedExtravasations of Anthracycline Anti-cancer AgentsJapan
-
San Diego Veterans Healthcare SystemCongressionally Directed Medical Research ProgramsCompletedPTSD With a History of Mild to Moderate TBIUnited States
-
Memorial Sloan Kettering Cancer CenterCompletedHistory of CancerUnited States
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruitingPatients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery
-
Stockton UniversityCompletedQuality of Life | Pain | Cancer Survivor | Balance | Function | Fall Risk | Chemotherapy Induced Peripheral NeuropathyUnited States
-
Universitaire Ziekenhuizen KU LeuvenCompletedExploration of How Patients Deal With Side Effects From ChemotherapyBelgium
-
University of Colorado, DenverBristol-Myers SquibbRecruitingTobacco Smoking | Bronchial Dysplasia | History of Non-Small Cell Lung Cancer | History of Head and Neck CancerUnited States
-
Liverpool University Hospitals NHS Foundation TrustUniversity Hospital Southampton NHS Foundation TrustCompletedCancer | Effects of ChemotherapyUnited Kingdom
-
Assistance Publique - Hôpitaux de ParisUnknownTo Compare the Monitoring of Circulating Tumor DNA With the Efficacy of Chemotherapy Evaluated by Computer Tomography Scan.France
-
Hadassah Medical OrganizationUnknownFemale Patients Aged 5-35 Prior to Systemic Chemotherapy | With Significant Risk of Ovarian ToxicityIsrael
Clinical Trials on Beetroot juice
-
Universidad Francisco de VitoriaUniversity of Alcala; University of SevilleCompleted
-
Bangor UniversityCompleted
-
University Hospital, GhentUniversity GhentTerminated
-
University of ManchesterCompleted
-
Queen Mary University of LondonCompleted
-
University of Colorado, BoulderRecruitingChronic Kidney DiseaseUnited States
-
Penn State UniversityActive, not recruitingMetabolic SyndromeUnited States
-
Wake Forest University Health SciencesCompletedStroke | Ischemic Stroke | Cerebrovascular AccidentUnited States
-
University of ReadingSaudi Cultural BureauCompletedNo Dental Disease | Non-smokingUnited Kingdom
-
Bournemouth UniversityInstitute of Bioengineering and Bioimaging (IBB); University of Portsmouth; Loughborough...Completed