The Effects of Anthracycline-based Chemotherapy on Peripheral Vascular Function
1 other identifier
observational
60
1 country
1
Brief Summary
The overall goal of this project is to determine the effects of anti-cancer chemotherapy on reflex control of blood pressure and vascular function. Recent data have demonstrated that cardiovascular disease-related mortality is the 2nd cause of morbidity and mortality for 7-year cancer survivors treated with chemotherapy. This anti-cancer treatment-mediated cardiotoxicity is a progressive process that begins at the molecular level, progresses to myocardial injury and left ventricular dysfunction, cumulating as heart failure and cardiovascular disease-related mortality. In parallel to these cardiac-specific changes, chemotherapy has also been shown to increase the risk for vascular-related abnormalities. However, the impact of adjuvant treatments on the function and structure of the peripheral vascular system remains poorly understood. With normal aging, two of the most important vascular adaptations to arteries, which strongly contribute to the increased risk of vascular-related and general cardiovascular disease, are an increase in large artery stiffness and dysfunction of the vascular endothelium. Therefore, the overall goal of this project is to determine the effects of anthracycline-based chemotherapy on large and small artery function and structure. The central hypothesis is that this type of cancer therapy results in negative vascular consequences as determined by non-invasive evaluation of spontaneous blood pressure control, carotid artery stiffness, and vascular endothelium-dependent vasodilation. This observational study is designed to increase our understanding of the vascular changes that occur during and following anti-cancer chemotherapy and provide insight into new methods that will decrease cardiovascular disease risk in those treated for cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedSeptember 2, 2025
August 1, 2025
1.5 years
February 16, 2017
August 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Spontaneous baroreflex sensitivity
Measured once in each experimental group
1 day
Acetylcholine induced cutaneous (skin) blood flow (%)
Measured once in each experimental group
1 day
Secondary Outcomes (2)
Carotid artery stiffness
1 day
Brachial-artery flow-mediated dilation
1 day
Study Arms (3)
Breast Cancer/Lymphoma Patient
Breast cancer or lymphoma patients currently undergoing anthracycline-based chemotherapy treatment. Patients are eligible if they have completed at least 1 cycle of chemotherapy. Free of known clinical cardiovascular disease.
Breast Cancer/Lymphoma Survivor
Individuals with history of breast cancer or lymphoma (1-5 years removed from last date of chemotherapy) who have a treatment history of anthracycline-based chemotherapy. Free of known clinical cardiovascular disease.
Control
Individuals with no history of caner or chemotherapy. Free of known clinical cardiovascular disease
Interventions
Continuously monitored for 5-30 minutes via finger photoplesmography
Assessment of carotid artery cross sectional area and intima-media thickness. Assessment of brachial artery diameter
Evaluation of oxidative stress via serum lipid hydroperoxide
Assessed non-invasively in the forearm skin via Laser Doppler flowmetry in response to locally delivered acetylcholine (ACh) and sodium nitroprusside (SNP) via iontophoresis.
Eligibility Criteria
Breast cancer and lymphoma patients (n =20) will enter the study following completion of at least 1 cycle of chemotherapy. Breast cancer and lymphoma survivors (n=20) will enter study if they are 1 - 5 years removed from last date of chemotherapy. Healthy control subjects (n=20) will be included in the study.
You may qualify if:
- Give voluntary consent to participate in the study
- (Group 1) Diagnosed Stage I-III breast cancer or lymphoma cancer with a \> 2 year life expectancy
- (Group 1) Current chemotherapy treatment includes anthracyclines
- (Group 2) History of Stage I-III breast cancer or lymphoma cancer with a \> 2 year life expectancy
- (Group 2) 1 - 5 years removed from last date of anthracycline-based chemotherapy
You may not qualify if:
- History of clinical cardiovascular disease (Atherosclerotic cardiovascular disease (ASCVD) defined by history of acute coronary syndromes, myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemia attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin)
- Not met the above criteria
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lafene Health Center
Manhattan, Kansas, 66502, United States
Related Publications (6)
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: 21689398BACKGROUNDMulrooney 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: 22456863BACKGROUNDChaosuwannakit 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: 19901105BACKGROUNDDuquaine 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: 14518612BACKGROUNDDidier KD, Ederer AK, Reiter LK, Brown M, Hardy R, Caldwell J, Black C, Bemben MG, Ade CJ. Altered Blood Flow Response to Small Muscle Mass Exercise in Cancer Survivors Treated With Adjuvant Therapy. J Am Heart Assoc. 2017 Feb 7;6(2):e004784. doi: 10.1161/JAHA.116.004784.
PMID: 28174169BACKGROUNDEderer AK, Didier KD, Reiter LK, Brown M, Hardy R, Caldwell J, Black CD, Larson RD, Ade CJ. Influence of Adjuvant Therapy in Cancer Survivors on Endothelial Function and Skeletal Muscle Deoxygenation. PLoS One. 2016 Jan 25;11(1):e0147691. doi: 10.1371/journal.pone.0147691. eCollection 2016.
PMID: 26807572BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 16, 2017
First Posted
February 24, 2017
Study Start
February 1, 2017
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
September 2, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share