Biliary Tract Cancer, Colorectal Cancer, Esophageal Cancer (EsC), Frailty, Gastric Cancer (GC), Gastrointestinal Cancers, Malnutrition Elderly, Older Adults (65 Years and Older), Pancreatic Cancer Resectable, Sarcopenia in Elderly, Toxicity Due to Chemotherapy
Conditions
Keywords
Frailty, G8 Screening Tool, VES-13, Chemotherapy Toxicity, Older adults, sarcopenia, malnutrition, Nutritional Assessment (MNA-SF), Activities of Daily Living (ADL, IADL), ECOG Performance Status, Supportive Oncology, Geriatric Oncology
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 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.
Interventions
OTHERAdjuvant 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.
Sponsors
Ankara Etlik City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-Related Toxicity | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Correlation of Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with sarcopenia risk assessed by the Strength, Assistance with walking, Rise from a chair, climb stairs, and Falls (SARC-F) questionnaire (range 0-10; cut-off ≥4; validated in Turkish). Scores will be reported as points on the scale. |
| 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 Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with nutritional risk assessed by the Mini Nutritional Assessment - Short Form (MNA-SF) questionnaire (range 0-14; categories: 12-14 = normal, 8-11 = risk, 0-7 = malnutrition; validated in Turkish). Scores will be reported as points on the scale. |
| 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 Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with functional independence assessed by the Katz Index of Activities of Daily Living (ADL; range 0-6; validated in Turkish). Scores will be reported as points on the scale. |
| 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) | Correlation of Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with functional independence assessed by the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale (range 0-8; validated in Turkish). Scores will be reported as points on the scale. |
| 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 Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with the Eastern Cooperative Oncology Group (ECOG) Performance Status (range 0-5; validated in Turkish). Scores will be reported as points on the scale. |
| Overall Survival (OS) | 12 months after chemotherapy initiation | Overall survival will be defined as the time from chemotherapy initiation to death from any cause, measured in months. |
| Progression-Free Survival (PFS) | 12 months after chemotherapy initiation. | Progression-free survival will be defined as the time from chemotherapy initiation to disease progression or death from any cause, measured in months. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORGalip Can Uyar, MD
Ankara Etlik City Hospital
Outcome results
None listed