NCT07456852

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

Vasotoxicity Surveillance Using EndoPAT: The VASA Pilot Study

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malignant Digestive System Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
DRUG	Capecitabine	Given IPO
DRUG	Diltiazem Hydrochloride	Given PO
PROCEDURE	Electrocardiogram	Undergo ECG
DRUG	Fluorouracil	Given IV
DEVICE	Holter Monitoring	Undergo Holter monitoring
DRUG	Isosorbide Mononitrate	Given PO
OTHER	Medical Device Usage and Evaluation	Use EndoPAT
DRUG	Placebo Administration	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-03-31
• Completion: 2030-03-31
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study