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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07151794
Enrollment
150
Registered
2025-09-03
Start date
2025-01-02
Completion date
2026-04-30
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geriatric Oncology, Nutrition, Nutrition Assessment, Oncology

Keywords

G-CSF, CARG, Frailty, Mini Nutritional Assessment (MNA)

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Çanakkale Onsekiz Mart University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Side effects of chemotherapyFrom enrollment to 6 month

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026