This phase I/II trial compares the effect of drugs that causes widening of blood vessels as a result of smooth muscle relaxation (vasodilator therapy) with isosorbide mononitrate, diltiazem or placebo to reduce vasotoxicity in patients with gastrointestinal cancer receiving fluoropyrimidine therapy. Some patients develop chest pain (possibly even a heart attack, a drop in heart function, or a rhythm abnormality) during treatment with a class of cancer drugs known as fluoropyrimidines, which include 5-Fluorouracil (5-FU) and capecitabine. These side effects are believed to be due to the development of an abnormal reactivity of the blood vessels referred to as vasospasm. Vasotoxicity is damage or toxicity inflicted upon blood vessels (vascular system), often causing dysfunction, remodeling, or narrowing (vasoconstriction). It is a broad term used to describe the detrimental effects of certain agents, such as chemotherapy drugs. Researchers want to evaluate how often the reactivity of blood vessels becomes abnormal, during the treatment with 5-FU or capecitabine and how clinically relevant and controllable/preventable this phenomenon is in patients with gastrointestinal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Undergo blood sample collection
Given IPO
Given PO
Undergo ECG
Given IV
Undergo Holter monitoring
Given PO
Use EndoPAT
Given PO
Ancillary studies
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in reactive hyperemia index (RHI)
Will be analyzed as a continuous variable and paired t-test or Wilcoxon signed-rank test will be used depending on parametric or non-parametric distribution of RHI values. Statistical significance is set at a p-value \< 0.05.
Time frame: Baseline (up to 3 days before start of infusion); during infusion; 12-36 hours post-infusion
Proportion of patients with RHI decline ≥ 20%
Assessed from baseline (prechemotherapy) to follow-up assessments during and after fluoropyrimidine exposure. Will be analyzed as a continuous variable and paired t-test or Wilcoxon signed-rank test will be used depending on parametric or non-parametric distribution of RHI values. Statistical significance is set at a p-value \< 0.05.
Time frame: Up to 1 year
Proportion of patients with absolute RHI ≤ 2.0
Assessed from baseline (prechemotherapy) to follow-up assessments during and after fluoropyrimidine exposure. Will be analyzed as a continuous variable and paired t-test or Wilcoxon signed-rank test will be used depending on parametric or non-parametric distribution of RHI values. Statistical significance is set at a p-value \< 0.05.
Time frame: Up to 1 year
High-sensitivity troponin T (hsTnT) (indicator of myocardial ischemia)
Will be compared between patients with and without a decline in RHI ≥20% from baseline.
Time frame: Up to 1 year
Presence of Holter abnormalities (ST-segment changes, arrhythmias)
Assessed using 48-hour continuous Holter monitoring. Will be compared between patients with and without a decline in RHI ≥20% from baseline.
Time frame: Up to 1 year
Presence of ischemic symptoms (angina or angina equivalents, dyspnea, claudication)
Will be compared between patients with and without a decline in RHI ≥20% from baseline.
Time frame: Up to 1 year
Seattle Angina Questionnaire (SAQ)
The Seattle Angina Questionnaire (SAQ) is a 19-item questionnaire used to assess self-reported health status and quality of life over the past 4 weeks in patients with coronary artery disease (CAD). Nine questions are answered on a 6-point scale (severely limited, moderately limited, somewhat limited, a little limited, not limited, limited, or did not do for other reasons). The remaining questions are answered using similar scales (e.g., not satisfied at all, mostly dissatisfied, somewhat satisfied, mostly satisfied, highly satisfied). Scores range from 0-100 with higher scores indicating better overall health (fewer symptoms).
Time frame: Baseline (up to 3 days before start of infusion); during infusion; 12-36 hours post-infusion
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