Risk of Chemotherapy Toxicity in Older Patients With Blood Cancer or Non-small Cell Lung Cancer

FITNESS: Calculating Risk of Chemotherapy Toxicity in Older Adults

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."

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Lung Non-Small Cell Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Procedure: Biospecimen Collection; Other: Questionnaire Administration; Procedure: Cognitive Assessment; Other: Physical Performance Testing

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with a hematologic malignancy and are either untreated or relapsed and newly diagnosed with NSCLC who intend to receive treatment at the Ohio State University

Description

Inclusion Criteria:

• Untreated for a hematologic malignancy or NSCLC malignancy with intention to receive treatment (i.e., chemotherapy, immunotherapy, targeted agents, bone marrow transplant, or other) at the Ohio State University; or patients with a relapsed hematologic malignancy intended to begin CAR T cell therapy
• Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)

Exclusion Criteria:

• Prisoners are excluded from participation
• Any medical condition including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study procedures

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (questionnaire, assessment, biospecimen); 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Biospecimen Collection; Undergo collection of blood and stool samples; Other: Questionnaire Administration; Complete questionnaire; Procedure: Cognitive Assessment; Complete thinking test; Other: Physical Performance Testing; Complete walking test; Other Names: Physical Fitness Testing; Physical Function Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic ability of the CARG chemotoxicity calculator in patients newly diagnosed with hematologic malignancy		365 days after first dose of chemotherapy
Predictive ability of the Cancer and Aging Research Group (CARG) Chemo-Toxicity calculator		365 days after first dose of chemotherapy
Predictive ability of Chemo-Toxicity calculator to predict grade 3-5 toxicity	Will fit a Cox regression model for time to toxicity (grades 3-5) containing the baseline chemo-toxicity risk score as the only predictor. The overall ability of the model to distinguish grade 3-5 from grade 1-2 toxicity will be evaluated using Harrell's C-statistic, which can be viewed as a generalization of the area under the curve measurement for receiver operator characteristics (ROC's) curves based on binary outcome data. A 95% confidence interval will be constructed for the C-statistic and if the lower bound is greater than 0.5 (expected value if the risk score is not predictive of toxicity) we will conclude that risk score is significantly able to distinguish between toxicity grades.	365 days after first dose of chemotherapy
Predictive ability of Geriatric Assessment (GA) metrics to predict grade 3-5 toxicity	Will fit a Cox regression model for time to toxicity (grades 3-5) containing the baseline chemo-toxicity risk score as the only predictor. The overall ability of the model to distinguish grade 3-5 from grade 1-2 toxicity will be evaluated using Harrell's C-statistic, which can be viewed as a generalization of the area under the curve measurement for ROC's curves based on binary outcome data. A 95% confidence interval will be constructed for the C-statistic and if the lower bound is greater than 0.5 (expected value if the risk score is not predictive of toxicity) we will conclude that risk score is significantly able to distinguish between toxicity grades.	365 days after first dose of chemotherapy
Association between frailty metrics and relative dose intensity (RDI)	Will explore the relationship of RDI and MAX2 (reduced and prescribed) with clinical and biologic factors of frailty. RDI (>= 85% versus [vs.] < 85%) will be treated as a continuous and dichotomous variable. The distribution of RDI and MAX2 will be examined graphically and transformed to normality as appropriate. Linear regression for continuous RDI and logistic regression for dichotomized RDI will be used to understand the relationship with RDI and independent variables (e.g. GA scores, age, short physical performance battery [SPPB] etc.) Stepwise regression will be used to identify significant clinical and biologic factors (e.g. OSU_Senescence) that are independently associated with continuous or dichotomized RDI.	365 days after first dose of chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship of frailty metrics with health related quality of life over time	Linear mixed models will be used in the analyses. Each model will include effects of each prognostic variable of interest, time (baseline vs. end of treatment), and time-by-prognostic variable interactions to determine if the associations between the prognostic variables and the outcome differs at baseline and end of treatment. An unstructured covariance matrix will be used to model the relationship between outcome measurements from the same patient.	365 days after first dose of chemotherapy
Relationship of frailty metrics with physical function	Linear mixed models will be used in the analyses. Each model will include effects of each prognostic variable of interest, time (baseline vs. end of treatment), and time-by-prognostic variable interactions to determine if the associations between the prognostic variables and the outcome differs at baseline and end of treatment. An unstructured covariance matrix will be used to model the relationship between outcome measurements from the same patient.	365 days after first dose of chemotherapy
Molecular markers of aging with risk of chemotherapy toxicity using the Chemo-Toxicity calculator	Will determine the association of molecular markers of aging with risk of chemotherapy toxicity using the Chemo-Toxicity calculator and other prognostic factors (e.g. age, disease, stage, body composition by imaging). Linear mixed models will be used in the analyses. Each model will include effects of each prognostic variable of interest, time (baseline vs. end of treatment), and time-by-prognostic variable interactions to determine if the associations between the prognostic variables and the outcome differs at baseline and end of treatment. An unstructured covariance matrix will be used to model the relationship between outcome measurements from the same patient.	365 days after first dose of chemotherapy

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Ashley E Rosko, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Hematologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Carcinoma, Non-Small-Cell Lung; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Behavioral Disciplines and Activities; Diagnostic Techniques, Respiratory System; Psychological Tests; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Respiratory Function Tests; Ergometry; Neuropsychological Tests; Exercise Test; Mental Status and Dementia Tests
• Other Study ID Numbers: OSU-18055; NCI-2020-01239 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No