{"type":"trials","record":{"id":35008,"source_id":"clinicaltrials-gov","external_id":"NCT07184047","title":"Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers","brief_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.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Ankara Etlik City Hospital","enrollment":72,"countries":["Turkey (Türkiye)"],"start_date":"2024-01-15","completion_date":"2026-02-19","last_update_date":"2026-02-20","source_url":"https://clinicaltrials.gov/study/NCT07184047","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":"TOX-FRAIL","age_range":"65 Years","comparator":null,"organization":"Ankara Etlik City Hospital","interventions":["Adjuvant Chemotherapy (Standard of Care)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-R…","Correlation of Frailty Scores with the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (S…","Correlation of Frailty Scores with the Mini Nutritional Assessment - Short Form (MNA-SF) Questionnaire — Baseline, 3 mo…","Correlation of Frailty Scores with the Katz Index of Activities of Daily Living (ADL) — Baseline, 3 months after chemot…","Correlation of Frailty Scores with the Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale — Baseline, 3…","Correlation of Frailty Scores with the Eastern Cooperative Oncology Group (ECOG) Performance Status — Baseline, 3 month…","Overall Survival (OS) — 12 months after chemotherapy initiation","Progression-Free Survival (PFS) — 12 months after chemotherapy initiation."],"design_description":null,"source_has_results":false},"controlled_terms":["Gastrointestinal Cancers","Frailty","Sarcopenia in Elderly","Malnutrition Elderly","Toxicity Due to Chemotherapy","Colorectal Cancer","Gastric Cancer (GC)","Pancreatic Cancer Resectable","Biliary Tract Cancer","Esophageal Cancer (EsC)","Older Adults (65 Years and Older)","Adjuvant Chemotherapy (Standard of Care)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct07184047","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-01-15 to 2026-02-19","comparator":null,"confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:25.799Z","intervention":["Adjuvant Chemotherapy (Standard of Care)"],"participants":72,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-R…","Correlation of Frailty Scores with the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (S…","Correlation of Frailty Scores with the Mini Nutritional Assessment - Short Form (MNA-SF) Questionnaire — Baseline, 3 mo…","Correlation of Frailty Scores with the Katz Index of Activities of Daily Living (ADL) — Baseline, 3 months after chemot…","Correlation of Frailty Scores with the Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale — Baseline, 3…","Correlation of Frailty Scores with the Eastern Cooperative Oncology Group (ECOG) Performance Status — Baseline, 3 month…","Overall Survival (OS) — 12 months after chemotherapy initiation","Progression-Free Survival (PFS) — 12 months after chemotherapy initiation."],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35008","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}