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临床试验/NCT07151794
NCT07151794进行中(未招募)不适用

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

Çanakkale Onsekiz Mart University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年1月2日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
150
试验地点
1
主要终点
Side effects of chemotherapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Side effects of chemotherapy

时间窗: From enrollment to 6 month

次要结局

未报告次要终点

研究者

发起方
Çanakkale Onsekiz Mart University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cemre Aydeğer

Research asistant

Çanakkale Onsekiz Mart University

研究点 (1)

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