Clinical Research Directory

FRAIL and FiND for Chemotherapy Toxicity in GI Cancer

Sponsor: Ankara Etlik City Hospital

Summary

Older adults with gastrointestinal cancer may experience serious side effects during chemotherapy, particularly when they have reduced physical strength, functional limitations, or other health conditions. Identifying patients at greater risk before treatment begins may help clinicians plan appropriate monitoring and supportive care. The FRAIL-GI study is an observational study evaluating two brief screening tools, the FRAIL scale and the Frail Non-Disabled (FiND) questionnaire, in adults aged 65 years or older receiving adjuvant chemotherapy for nonmetastatic gastrointestinal cancer. Both tools assess aspects of frailty and physical vulnerability, but they classify patients differently. The FRAIL scale evaluates fatigue, resistance, walking ability, illnesses, and weight loss. The FiND questionnaire assesses frailty-related symptoms while distinguishing patients with mobility disability from those without mobility disability. The main objective is to investigate whether frailty assessments performed before chemotherapy are associated with severe treatment-related side effects during the following 180 days. Severe toxicity is defined as a grade 3 or higher adverse event according to the Common Terminology Criteria for Adverse Events, version 5.0. The study also evaluates whether adding FRAIL or FiND information to routine clinical factors improves the identification of patients at increased risk of severe chemotherapy toxicity. Additional assessments examine treatment modifications, unplanned hospitalizations, and the availability of follow-up evaluations. All chemotherapy regimens and supportive treatments are determined by the treating oncology team according to routine clinical practice. Participation does not involve assignment to an experimental treatment.

Official title: FRAIL and FiND for Assessing Severe Chemotherapy Toxicity Risk in Older Adults With Gastrointestinal Cancer Receiving Adjuvant Chemotherapy

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