This trial evaluates the risk of chemotherapy toxicity in older patients with blood cancer or non-small cell lung cancer. The purpose of this study is to describe a patient’s wellness before and after chemotherapy treatment. This may help researchers better understand patient's ability to tolerate treatment and in the future devise the best treatment for a patient based on their “fitness.”
Additional locations may be listed on ClinicalTrials.gov for NCT05106374.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To validate the accuracy and predictive ability of the Cancer and Aging Research Group (CARG) Chemo-Toxicity calculator in untreated patients with hematologic malignancy and non-small cell lung cancer, as well as relapsed patients with a hematologic malignancy intended to begin chimeric antigen receptor (CAR) T cell therapy.
Ia. Determine if the CARG Chemo-Toxicity calculator predicts grade 3-5 toxicity in older adult patients with hematologic malignancy undergoing treatment.
Ib. Determine if CARG Geriatric Assessment (GA) metrics predict grade 3-5 toxicity in older adults with hematologic malignancy undergoing treatment.
Ic. Identify the association between frailty metrics and relative dose intensity in older adults with hematologic malignancy.
Id. To evaluate feasibility of CARG GA and functional assessment implementation in older adults with non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To determine the relationship of frailty metrics (CARG chemo-toxicity calculator and geriatric assessment metrics) with health related quality of life (HRQL) over time.
II. To identify the relationship of frailty metrics (chemo-toxicity calculator and GA metrics) with physical function as measured by the short physical performance battery (SPPB).
III. To determine the association of molecular markers of aging (OSU_Senescence, Hovarth epigenetic clock/deoxyribonucleic acid [DNA]ge, inflammatory cytokines, changes in peripheral blood T lymphocyte subsets) with risk of chemotherapy toxicity using the Chemo-Toxicity calculator and other prognostic factors (e.g. age, disease, stage, body composition by imaging).
IV. In the NSCLC cohort we will determine the association between treatment efficacy and toxicity with changes in the stool microbiome.
OUTLINE:
Patients complete questionnaires over 30-40 minutes about daily activity and feelings, complete thinking and walking tests over 10 minutes, and undergo collection of blood samples before the first dose of chemotherapy and 90, 180, and 365 days after first dose of chemotherapy. Patients with non-small lung cancer also undergo collection of stool sample.
After completion of study treatment, patients are followed up every 6 months.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorAshley E. Rosko
