Cardiovascular Function in Cancer Survivors

Cancer Survivor With History of Anthracycline Chemotherapy Clinical Trial

Official title:

Therapeutic Role of Dietary Nitrates on Cardiovascular Function in Cancer Survivors Treated With Anthracycline Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776149
• Other study ID #: Pro9264
• Status: Completed
• Phase: N/A
• Start date: May 10, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: March 2022
• Source: Kansas State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor With History of Anthracycline Chemotherapy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kansas State University - Clinical Integrative Physiology Laboratory	Manhattan	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Left ventricular function	Left ventricular function as measured by transthoracic echocardiography	The change between day 1 and day 21
Secondary	Change in Vascular function	Vascular function measured as changes in arterial stiffness and endothelial function.	The change between day 1 and day 21
Secondary	Change in Blood pressure	Local limb blood pressure measured in millimeters of mercury (mmHg) following study interventions/arms	The change between day 1 and day 21