RecruitingNot ApplicableNCT05010109

Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation

Longitudinal Assessment of Cardiovascular Injury and Cardiac Fitness in LA-NSCLC Patients Receiving Model Based Personalized Chemoradiation - an Adaptive Cohort Registration Study


Sponsor

M.D. Anderson Cancer Center

Enrollment

100 participants

Start Date

Jul 5, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC)
  • The recommended treatment is thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and/or immunotherapy) with or without neoadjuvant and/or adjuvant systemic therapy (chemotherapy, immunotherapy, targeted therapy)
  • \>/= 18 years of age
  • KPS \>/= 70
  • Willing and able to sign informed consents
  • Willing to perform 6minute walking test
  • Willing to preform required cardiac biomarker test for primary end point assessment.

Exclusion Criteria6

  • Unable or unwilling to give written informed consent
  • Previous history of RT to the thorax overlapping with the current treatment field.
  • Pregnant or breast-feeding
  • Renal failure necessitating dialysis
  • Unwilling to perform protocol tests
  • Contraindication for any protocol tests

Interventions

PROCEDURE6 Minute Walk Functional Test

Participate in 6 MWT

PROCEDUREBiospecimen Collection

Undergo blood and urine sample collection

PROCEDUREComputed Tomography

Undergo SPECT/CT

PROCEDUREEchocardiography

Undergo echocardiogram

PROCEDUREExercise Cardiac Stress Test

Undergo stress test

OTHERQuestionnaire Administration

Complete questionnaires

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT/CT


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05010109


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