Aging and Frailty Study

Aging Clinical Trial

Official title:

Aging Biomarkers, Geriatric Assessment and Electronic Frailty Index (AGE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268991
• Other study ID #: IRB00080711
• Secondary ID: WFBCCC 04721
• Status: Recruiting
• Start date: May 2, 2022
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: Study Coordinator
• Phone: 336-713-5440
• Email: jwmorgan[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Aging
• Effects of Chemotherapy
• Frailty

Intervention

Other:
• Geriatric Assessments and Frailty Indices
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

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Dose Delays During Chemotherapy	Dose delays greater than three days from planned treatment will be documented.	Up to 6 months after chemotherapy
Primary	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
Primary	Number of Unplanned Hospitalizations	Participants that required unplanned hospitalizations will be documented.	Up to 6 months after chemotherapy
Primary	Overall Survival	Participants will be followed after completion of chemotherapy for survival status.	Up to 6 months after chemotherapy