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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07456852
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Malignant Digestive System Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I (EndoPAT, ECG, Holter monitoring, blood sample)
    Patients undergo EndoPat, ECG, Holter monitoring for 48 hours, and blood sample collection during their SOC 5-FU infusion (any time from 2 hours after start to end of infusion) and 12-36 hours post-infusion or SOC capecitabine infusion 5-8 days after starting cycle 1 and 5-8 days after completing cycle 1, before beginning the next cycle of treatment.
  • Experimental: Phase II arm I (Isosorbide mononitrate)
    Patients receive isosorbide mononitrate PO QD for 7-12 days on study. Patients also undergo EndoPat, ECG, Holter monitoring for 48 hours, and blood sample collection on study.
  • Experimental: Phase II arm II (Diltiazem hydrochloride)
    Patients receive diltiazem PO QD for 7-12 days on study. Patients also undergo EndoPat, ECG, Holter monitoring for 48 hours, and blood sample collection on study.
  • Placebo Comparator: Phase II arm III (Placebo administration)
    Patients receive placebo PO QD for 7-12 days on study. Patients also undergo EndoPat, ECG, Holter monitoring for 48 hours, and blood sample collection on study.

Primary Outcome Measure

Change in reactive hyperemia index (RHI) [ Time Frame: Baseline (up to 3 days before start of infusion); during infusion; 12-36 hours post-infusion ]

Central Contacts

  • Clinical Trials Referral Office
    855-776-0015
    [email protected]
  • Interventional & Ischemic Heart Disease Research Team
    507-255-1724

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Interventional & Ischemic Heart Disease Research Team
507-255-1724
Joerg Herrmann, MD (PRINCIPAL_INVESTIGATOR)

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