Clinical trial NCT05106374: Risk of Chemotherapy Toxicity in Older Patients With Blood Cancer or Non-small Cell Lung Cancer
Official title: FITNESS: Calculating Risk of Chemotherapy Toxicity in Older Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Lung Non-Small Cell Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 182
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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."

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prognostic ability of the CARG chemotoxicity calculator in patients newly diagnosed with hematologic malignancy
timeFrame: 365 days after first dose of chemotherapy
measure: Predictive ability of the Cancer and Aging Research Group (CARG) Chemo-Toxicity calculator
timeFrame: 365 days after first dose of chemotherapy
measure: Predictive ability of Chemo-Toxicity calculator to predict grade 3-5 toxicity
timeFrame: 365 days after first dose of chemotherapy
measure: Predictive ability of Geriatric Assessment (GA) metrics to predict grade 3-5 toxicity
timeFrame: 365 days after first dose of chemotherapy
measure: Association between frailty metrics and relative dose intensity (RDI)
timeFrame: 365 days after first dose of chemotherapy
Secondary outcomes:
measure: Relationship of frailty metrics with health related quality of life over time
timeFrame: 365 days after first dose of chemotherapy
measure: Relationship of frailty metrics with physical function
timeFrame: 365 days after first dose of chemotherapy
measure: Molecular markers of aging with risk of chemotherapy toxicity using the Chemo-Toxicity calculator
timeFrame: 365 days after first dose of chemotherapy
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Ashley E Rosko, MD
role: PRINCIPAL_INVESTIGATOR
References: