Predicting Chemo Toxicity Using Geriatric Forms

September 1, 2025 updated by: Cemre Aydeğer, Çanakkale Onsekiz Mart University

Correlation and Comparison Analyses of CARG, G8, and Frailty Tests in Predicting Chemotherapy-Associated Toxicity: A Prospective Study

This prospective observational study aims to evaluate and compare the effectiveness of three geriatric assessment tools-CARG (Cancer and Aging Research Group score), G8 screening tool, and Frailty Scale-in predicting chemotherapy-related toxicity (CRT) in cancer patients aged 65 years and older. A total of at least 100 patients receiving standard chemotherapy (excluding hematologic malignancies and immunotherapy) at Çanakkale University Medical Faculty Oncology Clinic will be assessed prior to treatment initiation. Each participant will undergo baseline evaluations including G8, CARG, and Frailty assessments. The study will analyze the correlation between these tools and the occurrence of CRT using AUC, logistic regression, and correlation analyses. The goal is to identify the most accurate and practical screening tool to guide clinical decision-making and minimize chemotherapy toxicity in older adults.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Çanakkale, Turkey (Türkiye), 17020
        • Çanakkale Onsekiz Mart Univercity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will consist of adult oncology patients aged 65 years and older who are scheduled to receive systemic chemotherapy for solid tumors at the Çanakkale Onsekiz Mart University Medical Faculty, Department of Medical Oncology. Eligible participants must have a confirmed cancer diagnosis and a predefined chemotherapy regimen (adjuvant, neoadjuvant, or palliative), but must not have yet started treatment at the time of enrollment.

Description

Inclusion Criteria:

  • Patients aged 65 years or older.
  • Histologically confirmed cancer diagnosis with a pre-planned chemotherapy regimen (adjuvant, neoadjuvant, or palliative intent).
  • Chemotherapy not yet initiated at the time of enrollment.
  • Clinically stable condition, as assessed by the oncologist.
  • Willingness and ability to provide written informed consent.

Exclusion Criteria:

  • Presence of acute infection or advanced organ failure (cardiac, hepatic, or renal).
  • Severe psychiatric illness or cognitive impairment that interferes with the ability to complete assessments.
  • Patients receiving concurrent hormonal therapy, targeted therapy, immunotherapy, or radiotherapy.
  • Diagnosis of hematologic malignancies (e.g., leukemia, lymphoma, myeloma).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geriartric Form Results and Chemotherapy Side Effects
Time Frame: From enrollment to 6 month
ARG (Cancer and Aging Research Group score)
From enrollment to 6 month
G8 screening tool
Time Frame: From enrollment to 6 month
prediction side effets on chemotherapy on patient
From enrollment to 6 month
Frailty Scale
Time Frame: From enrollment to 6 month
Predicting side effect chemoterapy in elderly patient
From enrollment to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Çanakkale Onsekiz Mart University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Estimated)

December 20, 2025

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

July 30, 2025

First Submitted That Met QC Criteria

September 1, 2025

First Posted (Estimated)

September 9, 2025

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMU-FNO-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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