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

NCT05106374 | Completed

• 2 other identifiers: OSU-18055NCI-2020-01239
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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."

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Relationship of frailty metrics with health related quality of life over time

  365 days after first dose of chemotherapy

• Relationship of frailty metrics with physical function

  365 days after first dose of chemotherapy

• Molecular markers of aging with risk of chemotherapy toxicity using the Chemo-Toxicity calculator

  365 days after first dose of chemotherapy

Study Arms (1)

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.

Procedure: Biospecimen Collection; Procedure: Cognitive Assessment; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Cognitive Assessment PROCEDURE

Complete thinking test

Observational (questionnaire, assessment, biospecimen)

Physical Performance Testing OTHER

Complete walking test

Also known as: Physical Fitness Testing, Physical Function Testing

Observational (questionnaire, assessment, biospecimen)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Observational (questionnaire, assessment, biospecimen)

Questionnaire Administration OTHER

Complete questionnaire

Observational (questionnaire, assessment, biospecimen)

Biospecimen Collection PROCEDURE

Undergo collection of blood and stool samples

Observational (questionnaire, assessment, biospecimen)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Hematologic Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Mental Status and Dementia Tests; Exercise Test

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Ashley E Rosko, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: September 4, 2018
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)