Effectiveness of G8 and VES-13 Frailty Scales in Predicting Chemotherapy Toxicity in Older Patients With Gastrointestinal Cancers: A Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-Related Toxicity
Study Overview
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.
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥65 years
- •Histologically confirmed non-metastatic or locally advanced gastrointestinal cancers (esophageal, gastric, colorectal, pancreatic, biliary tract)
- •Planned to receive adjuvant chemotherapy (standard regimens such as FOLFOX, CAPEOX, FOLFIRI, FOLFOXIRI, FOLFIRINOX, capecitabine, gemcitabine, 5-FU/leucovorin, or oxaliplatin-based regimens)
- •ECOG Performance Status 0-2
- •Ability to complete frailty and functional assessment questionnaires (G8, VES-13, SARC-F, MNA-SF, Katz ADL, Lawton-Brody IADL)
- •Signed informed consent
Exclusion Criteria
- •ECOG Performance Status ≥3
- •Patients planned for neoadjuvant chemotherapy or chemoradiotherapy
- •Prior systemic chemotherapy or radiotherapy for the same cancer diagnosis
- •Severe cognitive impairment preventing questionnaire completion
- •Patients with advanced frailty at baseline screening
- •Concurrent enrollment in another interventional clinical trial
Arms & Interventions
Adjuvant Chemotherapy Cohort
Older patients (≥65 years) with non-metastatic or locally advanced gastrointestinal cancers receiving standard adjuvant chemotherapy (e.g., FOLFOX, CAPEOX, FOLFIRI, FOLFOXIRI, FOLFIRINOX, capecitabine, gemcitabine, 5-FU/leucovorin, or oxaliplatin-based regimens). Patients will undergo frailty, nutritional, sarcopenia, functional, and performance status assessments at baseline, 3 months, and at the end of chemotherapy. Treatment will follow routine clinical practice, and no investigational intervention will be administered.
Intervention: Adjuvant Chemotherapy (Standard of Care) (Other)
Outcomes
Primary Outcomes
Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-Related Toxicity
Time Frame: Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy)
The predictive ability of the G8 (score 0-17; cut-off ≤14) and VES-13 (score 0-13; cut-off ≥3) frailty screening tools in identifying older patients (≥65 years) with gastrointestinal cancers who are at risk of developing grade ≥2 chemotherapy-related toxicity. Toxicities will be assessed according to CTCAE version 5.0 and reported as the proportion (%) of patients with grade ≥2 events. Both frailty tools have validated Turkish versions.
Secondary Outcomes
- Correlation of Frailty Scores with the Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy).)
- Correlation of Frailty Scores with the Mini Nutritional Assessment - Short Form (MNA-SF) Questionnaire(Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy))
- Correlation of Frailty Scores with the Katz Index of Activities of Daily Living (ADL)(Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy))
- Correlation of Frailty Scores with the Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale(Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy))
- Overall Survival (OS)(12 months after chemotherapy initiation)
- Progression-Free Survival (PFS)(12 months after chemotherapy initiation.)
- Correlation of Frailty Scores with the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) Questionnaire(Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy))
Investigators
Galip Can Uyar
Medical Oncologist Specialist
Ankara Etlik City Hospital