Effects of ChemotherapyNCT05268991
Aging and Frailty Study
An observational study of Effects of Chemotherapy and Aging, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to compare methods to help personalize the prediction of chemotherapy side effects for older adults and to evaluate whether chemotherapy causes changes in the body that are associated with aging. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Effects of Chemotherapy, Aging, Frailty
- What is being tested?
- Geriatric Assessments and Frailty Indices
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 13 Jun 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Eligible participants will be identified by oncology providers, EPIC reports, or through screening of clinic schedules by the Cancer Control Survivorship Disease Oriented Team Clinical Trial Coordinator or research nurse
Who may be able to join
- Age 65 years and older
- Planned to initiate a new chemotherapy regimen
- Solid tumor malignancy of any stage or lymphoma
- Any performance status
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
- Life expectancy of ≥3 months
Who cannot join
- Initiating biologic, endocrine or immunotherapy only.
- Hematologic malignancy other than lymphoma.
- Concurrent radiation therapy.
- Planned inpatient chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Aging Biomarkers, Geriatric Assessment and Electronic Frailty Index (AGE)
The purpose of this research study is to compare methods to help personalize the prediction of chemotherapy side effects for older adults and to evaluate whether chemotherapy causes changes in the body that are associated with aging.
Read the detailed description
Primary Objective: Describe mean and variation of the electronic frailty index-cancer, geriatric measures, patient reported outcomes, and biomarkers of aging of chemotherapy, and their change.
- Conditions
- Effects of Chemotherapy, Aging, Frailty
- Being tested
- Geriatric Assessments and Frailty Indices
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Assessments and Frailty IndicesOther
Eligible and consented subjects will undergo a baseline assessment prior to chemotherapy initiation inclusive of geriatric/frailty assessments, patient reported outcomes and blood samples for biomarkers of aging. Assessment measures and blood samples will be repeated post cycle 1 and 2 of chemotherapy. Toxicity will be recorded from the medical record
| Study group | Role | What they receive |
|---|---|---|
| AGE Participants | Participants aged 65 and older with diagnosis of solid tumor malignancy or lymphoma and planned to start a new chemotherapy regimen in the outpatient setting Receives: Other: Geriatric Assessments and Frailty Indices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resiliency Administered Assessments - Change of Short Physical Performance Battery (SPPB)
The SPPB will be used to assess lower extremity physical function (a short walk of 4 meters, timed repeated chair stands and balances tests). Each task is scored ranging from 0-4 (0 = unable to complete; 4 = highest performance level) with the total sum score range from 0-12. Lower scores indicate increased risk of disability, hospitalization and worse survival among older adults with and without cancer.
Measured: At baseline, 3 months and 6 months after chemotherapy
Resiliency Administered Assessments - Change of Grip Strength
Grip strength in both hands will be measured using an adjustable, hydraulic grip strength dynamometer. Two trials will be conducted for each hand. Frailty by this criterion is defined by grip strength cutoffs which are dependent upon both gender and body mass index.
Measured: At baseline, 3 months and 6 months after chemotherapy
Resiliency Administered Assessments - Change of Blessed Orientation Memory and Concentration Test (BOMC)
A 6 item test that provides a measure of cognition. For items to 1 to 3 the response is either correct (score = 0) or incorrect (score = 1). For items 4 to 6, one point is added for each error (items 4 and 5 maximum error = 2; item 6 maximum error = 5). Maximum score = 28. Participants with scores ≥ 11 will receive further evaluation or intervention as deemed medically appropriate by the treating physician.
Measured: At baseline, 3 months and 6 months after chemotherapy
Change of Electronic Frailty Index and Cancer Score/Category
Measures collected from the resiliency assessments (Short Physical Performance Battery, Grip Strength, Blessed Orientation Memory and Concentration Test) will be used to calculate the Fried Frailty Index (FFI) to assess frailty. Scores will be anchored to the date of each assessment time point (i.e., baseline visit, follow-up visits). Each data element will be scored from 0 to 1 and the mean will be computed to calculate the overall score. Some data elements (e.g., comorbidities) will be coded as absent or present (0 or 1) and some (e.g., body mass index) will be assigned a score that ranges from 0 to 1. The higher score indicates a higher frailty of the participant.
Measured: At baseline, 3 months and 6 months after chemotherapy
Change in Patient Reported Outcomes Measurement - PROMIS 29
Measures collected from this is a 29-item self-reported measure including 4 items each for the following domains: physical function, anxiety, depression, fatigue, sleep disturbance, social function, and pain interference; plus 1 item measuring average pain intensity and cognition. Scoring is based on a 1-5 point Likert scale (1 = very often; 5 = never). Items are summed to create a total score that ranges from 6-30 and lower scores indicate greater self-reported difficulty.
Measured: At baseline, 3 months and 6 months after chemotherapy
Change of Biomarkers of Aging Observed During Study Intervention
Investigators will measure targeted panels of blood-based biomarkers including but not limited to serum Interleukin-6, tumor necrosis factor receptors, growth differentiating factor 15, and cystatin C.
Measured: At baseline, 3 months and 6 months after chemotherapy
Number of Incidences of Toxicity - Grades 2 to 5 Related to Standard of Care Chemotherapy
Grade 2 to 5 incidences of toxicities will be recorded and measured using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: Up to 6 months after chemotherapy
Number of Documented Dose Reductions During Chemotherapy
Participants that have the chemotherapy doses reduced during treatment will be documented.
Measured: Up to 6 months after chemotherapy
Number of Dose Delays During Chemotherapy
Dose delays greater than three days from planned treatment will be documented.
Measured: Up to 6 months after chemotherapy
Number of Early Discontinuations of Chemotherapy
Participants that have chemotherapy discontinued prior to anticipated completion of treatment will be documented.
Measured: Up to 6 months after chemotherapy
Number of Unplanned Hospitalizations
Participants that required unplanned hospitalizations will be documented.
Measured: Up to 6 months after chemotherapy
Overall Survival
Participants will be followed after completion of chemotherapy for survival status.
Measured: Up to 6 months after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start2 May 2022
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of ChemotherapyStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi Klepin, MD, MS, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268991
- Sponsor's protocol ID
- IRB00080711
- Other IDs
- WFBCCC 04721
- Status last verified
- Jul 2025
- First submitted
- 15 Feb 2022
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging Biomarkers, Geriatric Assessment and Electronic Frailty Index (AGE)
- ClinicalTrials.gov ID
- NCT05268991
- Acronym / sponsor ID
- IRB00080711
- Conditions
- Effects of Chemotherapy, Aging, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 7 Mar 2022 (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.
The purpose of this research study is to compare methods to help personalize the prediction of chemotherapy side effects for older adults and to evaluate whether chemotherapy causes changes in the body that are associated with aging.
Detailed description
Primary Objective: Describe mean and variation of the electronic frailty index-cancer, geriatric measures, patient reported outcomes, and biomarkers of aging of chemotherapy, and their change.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AGE Participants | – | Other: Geriatric Assessments and Frailty IndicesParticipants aged 65 and older with diagnosis of solid tumor malignancy or lymphoma and planned to start a new chemotherapy regimen in the outpatient setting |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Eligible participants will be identified by oncology providers, EPIC reports, or through screening of clinic schedules by the Cancer Control Survivorship Disease Oriented Team Clinical Trial Coordinator or research nurse
Key inclusion criteria (6 listed)
- Age 65 years and older
- Planned to initiate a new chemotherapy regimen
- Solid tumor malignancy of any stage or lymphoma
- Any performance status
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Key exclusion criteria (4 listed)
- Initiating biologic, endocrine or immunotherapy only.
- Hematologic malignancy other than lymphoma.
- Concurrent radiation therapy.
- Planned inpatient chemotherapy.
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 |
|---|---|---|
| Geriatric Assessments and Frailty IndicesEligible and consented subjects will undergo a baseline assessment prior to chemotherapy initiation inclusive of geriatric/frailty assessments, patient reported outcomes and blood samples for biomarkers of aging. Assessment measures and blood samples will be repeated post cycle 1 and 2 of chemotherapy. Toxicity will be recorded from the medical record | Other | AGE Participants |
Primary outcome
Resiliency Administered Assessments - Change of Short Physical Performance Battery (SPPB)
Time frame: At baseline, 3 months and 6 months after chemotherapy
The SPPB will be used to assess lower extremity physical function (a short walk of 4 meters, timed repeated chair stands and balances tests). Each task is scored ranging from 0-4 (0 = unable to complete; 4 = highest performance level) with the total sum score range from 0-12. Lower scores indicate increased risk of disability, hospitalization and worse survival among older adults with and without cancer.
Resiliency Administered Assessments - Change of Grip Strength
Time frame: At baseline, 3 months and 6 months after chemotherapy
Grip strength in both hands will be measured using an adjustable, hydraulic grip strength dynamometer. Two trials will be conducted for each hand. Frailty by this criterion is defined by grip strength cutoffs which are dependent upon both gender and body mass index.
Resiliency Administered Assessments - Change of Blessed Orientation Memory and Concentration Test (BOMC)
Time frame: At baseline, 3 months and 6 months after chemotherapy
A 6 item test that provides a measure of cognition. For items to 1 to 3 the response is either correct (score = 0) or incorrect (score = 1). For items 4 to 6, one point is added for each error (items 4 and 5 maximum error = 2; item 6 maximum error = 5). Maximum score = 28. Participants with scores ≥ 11 will receive further evaluation or intervention as deemed medically appropriate by the treating physician.
Change of Electronic Frailty Index and Cancer Score/Category
Time frame: At baseline, 3 months and 6 months after chemotherapy
Measures collected from the resiliency assessments (Short Physical Performance Battery, Grip Strength, Blessed Orientation Memory and Concentration Test) will be used to calculate the Fried Frailty Index (FFI) to assess frailty. Scores will be anchored to the date of each assessment time point (i.e., baseline visit, follow-up visits). Each data element will be scored from 0 to 1 and the mean will be computed to calculate the overall score. Some data elements (e.g., comorbidities) will be coded as absent or present (0 or 1) and some (e.g., body mass index) will be assigned a score that ranges from 0 to 1. The higher score indicates a higher frailty of the participant.
Change in Patient Reported Outcomes Measurement - PROMIS 29
Time frame: At baseline, 3 months and 6 months after chemotherapy
Measures collected from this is a 29-item self-reported measure including 4 items each for the following domains: physical function, anxiety, depression, fatigue, sleep disturbance, social function, and pain interference; plus 1 item measuring average pain intensity and cognition. Scoring is based on a 1-5 point Likert scale (1 = very often; 5 = never). Items are summed to create a total score that ranges from 6-30 and lower scores indicate greater self-reported difficulty.
Change of Biomarkers of Aging Observed During Study Intervention
Time frame: At baseline, 3 months and 6 months after chemotherapy
Investigators will measure targeted panels of blood-based biomarkers including but not limited to serum Interleukin-6, tumor necrosis factor receptors, growth differentiating factor 15, and cystatin C.
Number of Incidences of Toxicity - Grades 2 to 5 Related to Standard of Care Chemotherapy
Time frame: Up to 6 months after chemotherapy
Grade 2 to 5 incidences of toxicities will be recorded and measured using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Number of Documented Dose Reductions During Chemotherapy
Time frame: Up to 6 months after chemotherapy
Participants that have the chemotherapy doses reduced during treatment will be documented.
Number of Dose Delays During Chemotherapy
Time frame: Up to 6 months after chemotherapy
Dose delays greater than three days from planned treatment will be documented.
Number of Early Discontinuations of Chemotherapy
Time frame: Up to 6 months after chemotherapy
Participants that have chemotherapy discontinued prior to anticipated completion of treatment will be documented.
Number of Unplanned Hospitalizations
Time frame: Up to 6 months after chemotherapy
Participants that required unplanned hospitalizations will be documented.
Overall Survival
Time frame: Up to 6 months after chemotherapy
Participants will be followed after completion of chemotherapy for survival status.
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 1 Aug 2025.
- 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.
Heidi Klepin, MD, MS principal investigator
Wake Forest Baptist 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 Effects of Chemotherapy and Aging, run by Wake Forest University Health Sciences 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 6 inclusion and 4 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 1 Aug 2025. 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?
Resiliency Administered Assessments - Change of Short Physical Performance Battery (SPPB) (time frame: At baseline, 3 months and 6 months after chemotherapy). The study lists 12 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 1 Aug 2025.