Hematopoietic and Lymphoid Cell NeoplasmNCT05106374
Risk of Chemotherapy Toxicity in Older Patients With Blood Cancer or Non-small Cell Lung Cancer
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Lung Non-Small Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Lung Non-Small Cell Carcinoma
- What is being tested?
- Biospecimen Collection, Cognitive Assessment and Physical Performance Testing
- Type of treatment
- Surgery or procedure
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 22 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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."
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- Biospecimen Collection, Cognitive Assessment, Physical Performance Testing, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood and stool samples
Cognitive AssessmentProcedure or surgery
Complete thinking test
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Complete walking test
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Cognitive Assessment; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic ability of the CARG chemotoxicity calculator in patients newly diagnosed with hematologic malignancy
Measured: 365 days after first dose of chemotherapy
Predictive ability of the Cancer and Aging Research Group (CARG) Chemo-Toxicity calculator
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 365 days after first dose of chemotherapy
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 365 days after first dose of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start4 Sep 2018
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Rosko, Ohio State University Comprehensive Cancer Center
- Investigators
- Ashley E Rosko, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106374
- Sponsor's protocol ID
- OSU-18055
- Other IDs
- NCI-2020-01239
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FITNESS: Calculating Risk of Chemotherapy Toxicity in Older Adults
- ClinicalTrials.gov ID
- NCT05106374
- Acronym / sponsor ID
- OSU-18055
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire, assessment, biospecimen) | – | Procedure: Biospecimen Collection, Procedure: Cognitive Assessment, Other: Physical Performance Testing, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood and stool samples | Procedure or surgery | Observational (questionnaire, assessment, biospecimen) |
| Cognitive AssessmentComplete thinking test | Procedure or surgery | Observational (questionnaire, assessment, biospecimen) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingComplete walking test | Other | Observational (questionnaire, assessment, biospecimen) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Observational (questionnaire, assessment, biospecimen) |
| Questionnaire AdministrationComplete questionnaire | Other | Observational (questionnaire, assessment, biospecimen) |
Primary outcome
Prognostic ability of the CARG chemotoxicity calculator in patients newly diagnosed with hematologic malignancy
Time frame: 365 days after first dose of chemotherapy
Predictive ability of the Cancer and Aging Research Group (CARG) Chemo-Toxicity calculator
Time frame: 365 days after first dose of chemotherapy
Predictive ability of Chemo-Toxicity calculator to predict grade 3-5 toxicity
Time frame: 365 days after first dose of chemotherapy
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.
Predictive ability of Geriatric Assessment (GA) metrics to predict grade 3-5 toxicity
Time frame: 365 days after first dose of chemotherapy
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.
Association between frailty metrics and relative dose intensity (RDI)
Time frame: 365 days after first dose of chemotherapy
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.
3 secondary outcomes
Relationship of frailty metrics with health related quality of life over time
Time frame: 365 days after first dose of chemotherapy
Relationship of frailty metrics with physical function
Time frame: 365 days after first dose of chemotherapy
Molecular markers of aging with risk of chemotherapy toxicity using the Chemo-Toxicity calculator
Time frame: 365 days after first dose of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley E Rosko, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Lung Non-Small Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic ability of the CARG chemotoxicity calculator in patients newly diagnosed with hematologic malignancy (time frame: 365 days after first dose of chemotherapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.