Actively Recruiting
Vasotoxicity Surveillance Using EndoPAT: The VASA Pilot Study of Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy
Led by Mayo Clinic · Updated on 2026-06-02
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying vasotoxicity, which is damage to blood vessels, in patients with gastrointestinal cancer receiving fluoropyrimidine chemotherapy such as 5-Fluorouracil (5-FU) or capecitabine. The study aims to compare the effects of vasodilator drugs, specifically isosorbide mononitrate and diltiazem, against a placebo to see if these treatments can reduce abnormal blood vessel reactivity and related heart complications during chemotherapy. This phase I/II trial is assessing how often this blood vessel problem occurs and how manageable it is in these patients. Participants undergo various monitoring tests during their standard chemotherapy infusion cycles, including EndoPAT (a test for blood vessel function), electrocardiogram (ECG), Holter monitoring for 48 hours, and blood sample collection. Patients are randomly assigned to receive either isosorbide mononitrate, diltiazem, or a placebo taken by mouth once daily for 7 to 12 days while continuing their chemotherapy treatment. These tests are repeated during and after drug administration to evaluate changes. Throughout the study, participants complete questionnaires and have regular assessments of heart function and blood vessel health, including measuring reactive hyperemia index (RHI), troponin levels, and arrhythmias up to one year. Researchers also track symptoms like chest pain and breathing difficulties. The study involves baseline and follow-up visits to monitor safety and treatment impact, with a focus on changes in blood vessel behavior during chemotherapy. Participants are expected to attend multiple visits for testing and monitoring over the course of treatment and follow-up.
CONDITIONS
Brief Title
Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed gastrointestinal malignancy (colon, rectal, gastric, esophageal, or other GI cancer) for which fluoropyrimidine therapy (5-FU or capecitabine) is planned
- Planned initiation of infusional 5-FU or oral capecitabine therapy as chemotherapy or radiosensitizer
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Ability to return for baseline and follow-up EndoPAT testing, ECG, Holter monitoring, and blood draws
- Provide written informed consent
- Adequate baseline hemodynamic status: systolic blood pressure ≥ 120 mmHg and resting heart rate ≥ 70 beats/minute
- Completed phase I baseline and follow-up assessments including EndoPAT, ECG, hs-TnT, and Holter monitoring
- Demonstrated ≥ 20% decline in reactive hyperemia index (RHI) from baseline at phase I follow-up
- Adequate hemodynamic status before randomization: systolic blood pressure ≥ 120 mmHg and resting heart rate ≥ 70 beats/minute
- Ability to tolerate and comply with study medication
- Willingness to start study medication 5 days before and continue through assigned chemotherapy cycle
- Provide written informed consent for randomization phase
You will not qualify if you...
- Current or planned treatment with long-acting nitrates or calcium channel blockers at chemotherapy start
- Known allergy or contraindication to nitrates or calcium channel blockers
- Baseline systolic blood pressure below 120 mmHg or resting heart rate below 70 beats/minute
- History of myocardial infarction within 6 months or symptomatic heart failure requiring ongoing therapy
- Recent acute coronary syndrome or coronary revascularization within 3 months
- High-grade atrioventricular block without pacemaker
- Use of PDE-5 inhibitors (e.g., sildenafil) within 48 hours before enrollment
- Uncontrolled illness including unstable angina, arrhythmias, infection, or psychiatric/social conditions limiting study compliance
- Inability to undergo EndoPAT testing due to physical limitations
- Pregnant or nursing persons
- Concurrent enrollment in another interventional clinical trial that may interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants undergo baseline and follow-up assessments including EndoPAT, ECG, Holter monitoring for 48 hours, and blood sample collection during their standard chemotherapy infusion or oral capecitabine cycle.
1 to 2 visits depending on chemotherapy schedule
Duration - 7 to 12 days
Participants receive daily study medication (isosorbide mononitrate, diltiazem, or placebo) for 7 to 12 days during a chemotherapy cycle. During treatment, participants also undergo EndoPAT, ECG, Holter monitoring for 48 hours, and blood sample collection.
Approximately 1 baseline visit and 1 follow-up visit during treatment
Duration - Up to 1 year
Participants are monitored for up to 1 year to assess cardiac and vascular health including reactive hyperemia index changes, Holter abnormalities, ischemic symptoms, and questionnaire assessments.
Periodic visits as scheduled by study team
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
I
Interventional & Ischemic Heart Disease Research Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here