Trials / Completed

CompletedNCT07184047

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

Effectiveness of G8 and VES-13 Frailty Scales in Predicting Chemotherapy Toxicity in Older Patients With Gastrointestinal Cancers: A Prospective Observational Study

Status: Completed
Phase: —
Study type: Observational
Enrollment: 72 (actual)

Sponsor: Ankara Etlik City Hospital · Other Government
Sex: All
Age: 65 Years
Healthy volunteers: Not accepted

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.

Detailed description

Background Gastrointestinal (GI) cancers in older adults are often accompanied by frailty, malnutrition, and functional decline, which increase the risk of chemotherapy-related toxicity. While chemotherapy in the adjuvant setting is standard of care, toxicities may impair quality of life and adherence in this vulnerable population. Validated frailty screening tools may improve risk stratification and supportive care strategies. Study Design Type: Prospective, observational, single-center, non-randomized study Site: Ankara Etlik City Hospital, Department of Medical Oncology Target enrollment: 72 patients Population: Patients ≥65 years with non-metastatic or locally advanced GI cancers (esophageal, gastric, colorectal, pancreatic, or biliary tract) scheduled for adjuvant chemotherapy only Exclusion: ECOG PS ≥3, severe frailty at baseline, patients planned for chemoradiotherapy, or those receiving neoadjuvant chemotherapy Timeline: First patient in: January 15, 2024 Accrual closure: January 1, 2025 Final data collection (PFS/OS): January 1, 2026 Assessments Patients will be assessed at baseline, mid-treatment (\~3 months), and at the end of chemotherapy (\~6 months). All instruments have been validated in Turkish populations: G8 Screening Tool Range: 0-17 Cut-off ≤14 = frailty risk VES-13 (Vulnerable Elders Survey-13) Range: 0-13 Cut-off ≥3 = frailty SARC-F (Sarcopenia screening tool) Range: 0-10 Cut-off ≥4 = probable sarcopenia Mini Nutritional Assessment - Short Form (MNA-SF) 12-14 = normal nutrition 8-11 = at risk 0-7 = malnutrition Katz Index of Activities of Daily Living (ADL) Range: 0-6 (higher = more independence) Lawton-Brody Instrumental Activities of Daily Living (IADL) Range: 0-8 (higher = more independence) ECOG Performance Status Range: 0-5 (higher = worse functional state) Outcomes Primary outcome: Predictive value of G8 and VES-13 for grade ≥2 chemotherapy-related toxicity (CTCAE v5.0) Secondary outcomes: Associations between frailty and sarcopenia, nutrition, functional independence, and ECOG One-year Progression-Free Survival (PFS) One-year Overall Survival (OS) Statistical Analysis Categorical variables will be analyzed using Chi-square or Fisher's exact test. Continuous variables will be compared using t-test or Mann-Whitney U test, depending on distribution. Survival analyses (PFS, OS) will be estimated with Kaplan-Meier method. A p-value \<0.05 will be considered statistically significant.

Conditions

Interventions

Type	Name	Description
OTHER	Adjuvant Chemotherapy (Standard of Care)	Patients aged 65 years and older with non-metastatic or locally advanced gastrointestinal cancers will receive standard adjuvant chemotherapy regimens as part of routine clinical practice. Regimens may include FOLFOX, CAPEOX, FOLFIRI, FOLFOXIRI, FOLFIRINOX, capecitabine, gemcitabine, 5-FU/leucovorin, or oxaliplatin-based combinations, depending on tumor type and physician decision. No investigational drugs or experimental interventions are administered. The study is observational, and all treatments follow standard of care.

Timeline

Start date: 2024-01-15
Primary completion: 2025-02-01
Completion: 2026-02-19
First posted: 2025-09-19
Last updated: 2026-02-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07184047. Inclusion in this directory is not an endorsement.