Vasodilator Therapy to Reduce Vascular Side Effects in GI Cancer Patients on Fluoropyrimidines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 trial investigates whether vasodilators can lessen vasotoxicity in patients with malignant digestive system neoplasms receiving fluoropyrimidine therapy. Participants are assigned to receive isosorbide mononitrate, diltiazem, or placebo, and are monitored for cardiovascular reactions during treatment with 5-FU or capecitabine. The study includes assessments such as EndoPAT testing, ECG, Holter monitoring, and regular blood work. It is conducted at Mayo Clinic in Rochester, with eligibility limited to adults capable of returning for all required evaluations. The goal is to determine safety and preliminary efficacy signals for reducing chemotherapy-associated vascular toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* REGISTRATION: Age ≥ 18 years
* REGISTRATION: Histologically or cytologically confirmed gastrointestinal malignancy (colon, rectal, gastric, esophageal, or other GI cancer) for which fluoropyrimidine therapy (5-FU or capecitabine) is indicated, either as single agent or in combination with other systemic therapy
* REGISTRATION: Planned initiation of 5-FU (infusional) or oral capecitabine therapy, either as standard chemotherapy or as a radiosensitizer
* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* REGISTRATION: Ability to return to Mayo Clinic for baseline and follow-up EndoPAT testing, electrocardiogram (ECG), Holter monitoring, and blood draws
* REGISTRATION: Provide written informed consent
* REGISTRATION: Adequate baseline hemodynamic status: systolic blood pressure ≥ 120 mmHg and resting heart rate ≥ 70 beats/minute (to ensure safety for potential vasodilator therapy in Phase II)
* RANDOMIZATION: Completed all phase I baseline and follow-up assessments, including EndoPAT, ECG, high-sensitivity cardiac troponin T (hs-TnT), and Holter monitoring
* RANDOMIZATION: Demonstrated a ≥ 20% decline in reactive hyperemia index (RHI) from baseline at either phase I follow-up assessment as measured by EndoPAT
* RANDOMIZATION: Adequate hemodynamic status prior to randomization: systolic blood pressure ≥ 120 mmHg and resting heart rate ≥ 70 beats/minute
* RANDOMIZATION: Ability to tolerate and comply with study medication (isosorbide mononitrate, diltiazem, or placebo) per investigator assessment
* RANDOMIZATION: Willingness to initiate study medication 5 days before and continue through the assigned fluoropyrimidine treatment cycle
* RANDOMIZATION: Provide written informed consent for randomization phase

Exclusion Criteria:

* REGISTRATION: Current or planned treatment with long-acting nitrates or calcium channel blockers at the time of fluoropyrimidine initiation
* REGISTRATION: Known hypersensitivity or contraindication to nitrates or calcium channel blockers
* REGISTRATION: Baseline systolic blood pressure \< 120 mmHg or resting heart rate \< 70 beats/minute
* REGISTRATION: History of myocardial infarction ≤ 6 months prior to registration, or symptomatic heart failure \[decompensated or New York Heart Association (NYHA) III-IV\] requiring ongoing therapy
* REGISTRATION: Recent acute coronary syndrome or coronary revascularization within 3 months of enrollment
* REGISTRATION: High-grade atrioventricular (AV) block without pacemaker
* REGISTRATION: Use of PDE-5 inhibitors \[e.g. sildenafil (Viagra)\] within 48 hours of enrollment
* REGISTRATION: Uncontrolled intercurrent illness including but not limited to: unstable angina, symptomatic arrhythmias, uncontrolled infection, or psychiatric/social conditions limiting compliance with study requirements
* REGISTRATION: Physical inability to undergo EndoPAT testing (e.g., digital amputation, severe hand deformity, or other limiting condition)
* REGISTRATION: Pregnant or nursing persons
* REGISTRATION: Concurrent enrollment in another interventional clinical trial that, in the opinion of the investigator, would interfere with study endpoints

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Joerg Herrmann, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.