Clinical trial NCT05268991: Aging and Frailty Study
Official title: Aging Biomarkers, Geriatric Assessment and Electronic Frailty Index (AGE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Effects of Chemotherapy
Aging
Frailty
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Resiliency Administered Assessments - Change of Short Physical Performance Battery (SPPB)
timeFrame: At baseline, 3 months and 6 months after chemotherapy
measure: Resiliency Administered Assessments - Change of Grip Strength
timeFrame: At baseline, 3 months and 6 months after chemotherapy
measure: Resiliency Administered Assessments - Change of Blessed Orientation Memory and Concentration Test (BOMC)
timeFrame: At baseline, 3 months and 6 months after chemotherapy
measure: Change of Electronic Frailty Index and Cancer Score/Category
timeFrame: At baseline, 3 months and 6 months after chemotherapy
measure: Change in Patient Reported Outcomes Measurement - PROMIS 29
timeFrame: At baseline, 3 months and 6 months after chemotherapy
measure: Change of Biomarkers of Aging Observed During Study Intervention
timeFrame: At baseline, 3 months and 6 months after chemotherapy
measure: Number of Incidences of Toxicity - Grades 2 to 5 Related to Standard of Care Chemotherapy
timeFrame: Up to 6 months after chemotherapy
measure: Number of Documented Dose Reductions During Chemotherapy
timeFrame: Up to 6 months after chemotherapy
measure: Number of Dose Delays During Chemotherapy
timeFrame: Up to 6 months after chemotherapy
measure: Number of Early Discontinuations of Chemotherapy
timeFrame: Up to 6 months after chemotherapy
measure: Number of Unplanned Hospitalizations
timeFrame: Up to 6 months after chemotherapy
measure: Overall Survival
timeFrame: Up to 6 months after chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Heidi Klepin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: