Breast Cancer Clinical Trial
Official title:
The Effects of Anthracycline-based Chemotherapy on Spontaneous Baroreflex Sensitivity, Carotid Artery Stiffness, and Endothelial-dependent Vascular Function.
NCT number | NCT03062878 |
Other study ID # | Pro8425 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2017 |
Est. completion date | August 1, 2018 |
Verified date | March 2022 |
Source | Kansas State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 1, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Lafene Health Center | Manhattan | Kansas |
Lead Sponsor | Collaborator |
---|---|
Carl Ade, M.S., Ph.D. |
United States,
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
Didier 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). pii: e004784. doi: 10.1161/JAHA.116.004784. — 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
Ederer 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. — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spontaneous baroreflex sensitivity | Measured once in each experimental group | 1 day | |
Primary | Acetylcholine induced cutaneous (skin) blood flow (%) | Measured once in each experimental group | 1 day | |
Secondary | Carotid artery stiffness | Measured once in each experimental group | 1 day | |
Secondary | Brachial-artery flow-mediated dilation | Measured once in each experimental group | 1 day |
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