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

NCT07184047 | Completed

• 1 other identifier: AEŞH-BADEK-2024-039
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancers; Frailty; Sarcopenia in Elderly; Malnutrition Elderly; Colorectal Cancer; Gastric Cancer (GC); Pancreatic Cancer Resectable; Biliary Tract Cancer; Esophageal Cancer (EsC); Older Adults (65 Years and Older); Toxicity Due to Chemotherapy

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

Outcome Measures

Primary Outcomes (1)

• Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-Related Toxicity

  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.

  Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy)

Secondary Outcomes (7)

• 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 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)

• 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).

Study Arms (1)

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.

Other: Adjuvant Chemotherapy (Standard of Care)

Interventions

Adjuvant Chemotherapy (Standard of Care) OTHER

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.

Adjuvant Chemotherapy Cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of at least 72 older patients (≥65 years) with non-metastatic or locally advanced gastrointestinal cancers who are scheduled to receive standard adjuvant chemotherapy at Ankara Etlik City Hospital, Department of Medical Oncology. Patients will be assessed for frailty, sarcopenia, nutritional status, functional independence, and performance status at baseline, 3 months, and 6 months during chemotherapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital, Medical Oncology Department

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Frailty; Colorectal Neoplasms; Stomach Neoplasms; Biliary Tract Neoplasms; Esophageal Neoplasms; Sarcopenia; Malnutrition; Sarcoglycanopathies

Interventions

Chemotherapy, Adjuvant; Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Biliary Tract Diseases; Head and Neck Neoplasms; Esophageal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Dystrophies, Limb-Girdle; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Respiration Disorders; Respiratory Tract Diseases; Neuromuscular Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Galip Can Uyar, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist Specialist

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 19, 2025
• Study Start: January 15, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 19, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)