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Completed NCT07272538

FRAIL and FiND for Chemotherapy Toxicity in GI Cancer

Conditions: Gastrointestinal Cancers, Frailty at Older Adults, Chemotherapy

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Enrollment: 122
Sponsor: Ankara Etlik City Hospital

Location: Etlik City Hospital Medical Oncology Department Ankara Yenimahalle

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.

Eligibility Criteria

Inclusion Criteria: * Age ≥65 years. * Histologically confirmed gastrointestinal malignancy, including colorectal, gastric, gastroesophageal junction, pancreatic, biliary tract, esophageal, or small intestinal cancer. * Curative-intent surgical resection with a plan for standard adjuvant chemotherapy. * Initiation of adjuvant chemotherapy during the study period. * Baseline assessment using the FRAIL (Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight) scale and FiND (Frail Non-Disabled) questionnaire before chemotherapy initiation. * Ability to provide informed consent and participate in clinical follow-up. Exclusion Criteria: * Age \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07272538). StuddyBuddy aggregates publicly available trial information.