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Active, Not Recruiting

NCT Number: NCT07151794

G8, CARG, Frailty, and Nutritional Markers in Predicting Chemotoxicity

This study aims to evaluate the ability of G8, CARG, and Frailty scales to predict chemotherapy-related toxicity and the need for G-CSF in elderly cancer patients. It also investigates their correlation with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP) and the Mini Nutritional Assessment (MNA) test.

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)

About this study

Background: Aging is associated with decreased physiological reserves, making elderly cancer patients more vulnerable to chemotherapy toxicity (CT). Traditional performance scales like ECOG may be insufficient for treatment decisions. Tools such as G8, Clinical Frailty Scale (CFS), and the Cancer and Aging Research Group (CARG) score are practical screening instruments recommended by ASCO and SIOG, yet their combined predictive accuracy for CT and granulocyte colony-stimulating factor (G-CSF) usage remains underexplored.

Objectives: This prospective study aims to evaluate the predictive performance of the G8, CARG, and Frailty scales-alone and in combination with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP)-in forecasting chemotherapy-related toxicity and G-CSF need. It also investigates the correlation between these geriatric assessment tools and Mini Nutritional Assessment (MNA) scores.

Methods: The study will be conducted at Çanakkale University Medical Faculty Oncology Outpatient Clinic. Patients aged 65 and above with a planned chemotherapy regimen will be recruited. Before the first chemotherapy cycle, patients will undergo G8, CARG, Frailty, and MNA assessments. Nutritional biomarkers will be extracted from pre-treatment routine lab tests. Chemotherapy toxicity and G-CSF requirement will be monitored across treatment cycles. ROC, correlation, and regression analyses will be conducted to evaluate predictive validity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 65 years
  • Diagnosed with solid tumor malignancy
  • Planned to undergo at least two cycles of adjuvant, neoadjuvant, or metastatic chemotherapy
  • Clinically stable condition
  • Provided written informed consent

Exclusion criteria

  • Presence of hematological malignancies
  • Concurrent hormonal therapy, targeted therapy, immunotherapy, or radiotherapy
  • Acute infection or advanced organ failure (cardiac, hepatic, renal)
  • Cognitive or psychiatric impairment preventing test participation
  • Prior treatment with G-CSF

Treatment and study plan

Primary outcomes

  1. Side effects of chemotherapy

    Time frame: From enrollment to 6 month

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Official study title

Correlation of G8, CARG, and Frailty Scales With Nutritional Biomarkers and G-CSF Requirement in Elderly Cancer Patients: A Prospective Study on Predicting Chemotherapy Toxicity

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Sep 3, 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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