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Longitudinal Geriatric Vulnerability, Chemotherapy Toxicity, and Functional Outcomes in Older Adults With Gastrointestinal Cancer
Sponsor: Ankara Etlik City Hospital
Summary
Older adults with gastrointestinal cancers may be more likely to experience side effects from chemotherapy and difficulties with everyday activities. These problems are not always explained by age alone. Changes in nutrition, physical strength, general health, and independence may also affect how well a person tolerates cancer treatment. The purpose of the VITAL-GI study is to better understand how health-related vulnerability in older adults is associated with chemotherapy side effects and changes in daily functioning over time. This is an observational study involving adults aged 65 years or older with gastrointestinal cancer that has not spread to distant parts of the body. Participants receive chemotherapy as part of their usual medical care, either before or after surgery, according to their treatment plan. The study does not assign chemotherapy treatments or change routine care. Researchers use questionnaires and clinical information to assess general health, nutrition, physical abilities, independence, and the risk of chemotherapy side effects. Assessments are performed when chemotherapy begins and approximately 3 and 6 months later. The study examines whether initial health assessments can help identify people who are more likely to experience serious chemotherapy side effects. It also examines how health, daily activities, symptoms, and quality of life change during treatment. The findings may help researchers better understand the supportive care needs of older adults receiving chemotherapy for gastrointestinal cancer.
Official title: Beyond Baseline Frailty Screening: Longitudinal Geriatric Vulnerability, Severe Chemotherapy Toxicity, and Functional Decline in Older Adults With Nonmetastatic Gastrointestinal Cancer
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
OBSERVATIONAL
Enrollment
132
Start Date
2024-01-15
Completion Date
2026-02-19
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Standard-of-Care Systemic Chemotherapy
Participants receive standard-of-care adjuvant or neoadjuvant chemotherapy for nonmetastatic or locally advanced gastrointestinal cancer, as determined by the treating oncologist according to tumor characteristics, disease stage, treatment intent, and established clinical practice. Chemotherapy regimens may include CAPOX, FOLFOX, capecitabine monotherapy, modified FOLFIRINOX, gemcitabine monotherapy, FLOT, or gemcitabine plus capecitabine, as clinically appropriate. Treatment selection, dosing, modifications, and supportive care are not assigned or directed by the study. The observational assessments do not involve any experimental drugs or investigational therapeutic interventions.
Locations (1)
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye)