Effectiveness of G8 and VES-13 Frailty Scales in Predicting Chemotherapy Toxicity in Older Patients With Gastrointestinal Cancers: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-Related Toxicity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Adjuvant Chemotherapy (Standard of Care) (Other)
结局指标
主要结局
Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-Related Toxicity
时间窗: 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.
次要结局
- 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))
研究者
Galip Can Uyar
Medical Oncologist Specialist
Ankara Etlik City Hospital