Clinical Trial

Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers

Study acronym: TOX-FRAIL
Completed
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Summary
This study evaluates the effectiveness of the G8 and VES-13 frailty scales in predicting chemotherapy-related toxicity in older patients with gastrointestinal cancers receiving adjuvant chemotherapy. Older adults are more vulnerable to treatment-related side effects due to age-related declines in physiological reserve. Early identification of frailty may help individualize treatment decisions and optimize supportive care. This is a prospective, single-center, observational study conducted at Ankara Etlik City Hospital. A total of 72 patients aged 65 years and older with non-metastatic or locally advanced gastrointestinal cancers scheduled for adjuvant chemotherapy will be included. Frailty, sarcopenia, nutritional status, functional independence, and performance status will be assessed at baseline, 3 months, and at the end of chemotherapy. The primary aim is to determine the predictive value of G8 and VES-13 scores for chemotherapy-related toxicity. Secondary aims include exploring the associations between frailty, nutritional status, sarcopenia, daily living activities, and treatment tolerance. Additionally, one-year progression-free survival (PFS) and overall survival (OS) will be analyzed.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-14; most recent amendment 2026-02-19.
Status change: Active, Not Recruiting → Completed 2026-02-19
Trial Details
NCT Number NCT07184047
Lead Sponsor Ankara Etlik City Hospital
Conditions Gastrointestinal Cancers, Frailty, Sarcopenia in Elderly, Malnutrition Elderly, Toxicity Due to Chemotherapy, Colorectal Cancer, Gastric Cancer (GC), Pancreatic Cancer Resectable +3 more
Enrollment 72 participants
Start Date 2024-01-15
Primary Completion 2025-02-01 (estimated)
Study Completion 2026-02-19 (estimated)
Updated on ClinicalTrials.gov 2026-02-20