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Active, Not Recruiting

NCT Number: NCT07163169

Predicting Chemo Toxicity Using Geriatric Forms

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Çanakkale Onsekiz Mart Univercity

Çanakkale, 17020, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Geriartric Form Results and Chemotherapy Side Effects

    Time frame: From enrollment to 6 month

    ARG (Cancer and Aging Research Group score)

  2. G8 screening tool

    Time frame: From enrollment to 6 month

    prediction side effets on chemotherapy on patient

  3. Frailty Scale

    Time frame: From enrollment to 6 month

    Predicting side effect chemoterapy in elderly patient

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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