Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation
Recruiting · NCT05010109 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
6 Minute Walk Functional TestBiospecimen CollectionComputed TomographyEchocardiographyExercise Cardiac Stress TestQuestionnaire AdministrationSingle Photon Emission Computed Tomography
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- M D Anderson Cancer Center - Houston, Texas, United States