Aging and Frailty Study

NCT ID: NCT05268991

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-02

Study Completion Date

2025-06-13

Brief Summary

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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

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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

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Effects of Chemotherapy Aging Frailty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Geriatric Assessments and Frailty Indices

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heidi Klepin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Locations

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Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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WFBCCC 04721

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00080711

Identifier Type: -

Identifier Source: org_study_id

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