Cardiovascular Function in Cancer Survivors

NCT03776149 | Completed

• 1 other identifier: Pro9264
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivor With History of Anthracycline Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Change in Left ventricular function

  Left ventricular function as measured by transthoracic echocardiography

  The change between day 1 and day 21

Secondary Outcomes (2)

• Change in Vascular function

  The change between day 1 and day 21

• Change in Blood pressure

  The change between day 1 and day 21

Study Arms (2)

Beetroot juice (dietary nitrate)

EXPERIMENTAL

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

Black currant juice (placebo control)

PLACEBO COMPARATOR

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

Interventions

Beetroot juice 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.

Beetroot juice (dietary nitrate)

Black currant juice 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)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cancer survivors (at least 1 year post treatment)
• Prior administration of anthracycline chemotherapy
• partial/complete remission

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas State University: lead

Study Sites (1)

Kansas State University - Clinical Integrative Physiology Laboratory

Manhattan, Kansas, 66506, United States

Location

Related Publications (4)

• 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.

  PMID: 21689398 BACKGROUND

• 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.

  PMID: 22456863 BACKGROUND

• 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.

  PMID: 19901105 BACKGROUND

• 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.

  PMID: 14518612 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: December 14, 2018
• Study Start: May 10, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)