Study of Vasodilator Medicines to Reduce Blood Vessel Damage in Gastrointestinal Cancer Patients Receiving Fluoropyrimidine Chemotherapy

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 III 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.

Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy