Trials / Completed

CompletedNCT04183218

Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

Status: Completed
Phase: —
Study type: Observational
Enrollment: 24 (actual)

Sponsor: Mayo Clinic · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This trial studies cardiac changes after radiation or chemo-radiation for the treatment of lung or esophageal cancer that has not spread to other places in the body (non-metastatic) or has not come back (non-recurrent). Continuous cardiac monitoring with an implanted device may help to identify cardiac changes that would remain unnoticed, and facilitate the treatment of these early cardiac changes as part of standard care.

Detailed description

PRIMARY OBJECTIVE: I. To determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer. EXPLORATORY OBJECTIVES: I. Define the spectrum of cardiac toxicity among chemoradiotherapy (CRT) patients at highest risk of cardiac toxicity. II. Establish the timeline of cardiac toxicity development and identify early predictive findings of permanent damage. III. Characterize the areas of the heart at highest risk for persistent cardiac damage. IV. Identify a dose response threshold for radiotherapy (RT) damage in different areas of the heart. V. Improve survival by alerting the cardiology team of the need for life-saving standard of care interventions. VI. Describe medical interventions employed for the cardiac events identified in the study. OUTLINE: Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months. After completion of study treatment, patients are followed up at 4 weeks, 3, 9 and 12 months post RT.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo biospecimen collection
DEVICE	Cardiac Event Monitor	Receive cardiac monitor
OTHER	Chemoradiotherapy	Undergo CRT
RADIATION	Radiation Therapy	Undergo RT

Timeline

Start date: 2019-09-23
Primary completion: 2024-01-06
Completion: 2024-05-02
First posted: 2019-12-03
Last updated: 2024-08-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04183218. Inclusion in this directory is not an endorsement.