Aging and Frailty Study

NCT05268991 | Completed DMC

• 2 other identifiers: IRB00080711WFBCCC 04721
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Effects of Chemotherapy; Aging; Frailty

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Up to 6 months after chemotherapy

• Number of Dose Delays During Chemotherapy

  Dose delays greater than three days from planned treatment will be documented.

  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.

  Up to 6 months after chemotherapy

• Number of Unplanned Hospitalizations

  Participants that required unplanned hospitalizations will be documented.

  Up to 6 months after chemotherapy

• Overall Survival

  Participants will be followed after completion of chemotherapy for survival status.

  Up to 6 months after chemotherapy

Study Arms (1)

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

Other: Geriatric Assessments and Frailty Indices

Interventions

Geriatric Assessments and Frailty Indices OTHER

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

AGE Participants

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Initiating biologic, endocrine or immunotherapy only.
• Hematologic malignancy other than lymphoma.
• Concurrent radiation therapy.
• Planned inpatient chemotherapy.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Heidi Klepin, MD, MS

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 7, 2022
• Study Start: May 2, 2022
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)