NCT07272538

Predicting Chemotherapy Toxicity Using FRAIL and FIND in Older Adults With Gastrointestinal Cancers

The Role of FRAIL and FIND Frailty Scales in Predicting Chemotherapy-Related Toxicity Among Older Adults Receiving Adjuvant Treatment for Gastrointestinal Cancers: A Prospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Ankara Etlik City Hospital · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This observational study evaluated whether two frailty screening tools, the FRAIL scale and the FiND questionnaire, can predict chemotherapy-related side effects in older adults with gastrointestinal cancers. Patients aged 65 years or older who received standard adjuvant chemotherapy after curative surgery for cancers of the colon, rectum, stomach, pancreas, or esophagus were included. No experimental treatment was given, and all patients received routine chemotherapy determined by their treating oncologists. Frailty was assessed at the beginning of chemotherapy, around the middle of treatment, and at the end of therapy. Side effects were recorded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The main goal was to determine whether baseline frailty scores were associated with severe (Grade 3 or higher) chemotherapy toxicity. Additional goals included understanding how nutritional status, performance status, and comorbidities were related to toxicity and treatment completion. The study collected real-world data to help identify older patients at higher risk of toxicity and to support safer, more personalized decision-making in routine oncology practice.

Detailed description

This prospective observational study evaluated the relationship between frailty and chemotherapy-related toxicity in older adults with gastrointestinal cancers. Frailty was assessed using two validated screening tools: the FRAIL scale and the FiND questionnaire. Both tools are short, patient-reported screening instruments designed to identify vulnerability, reduced physiological reserve, and early mobility limitations in older adults. Both frailty instruments (FRAIL and FiND) have validated Turkish-language versions, ensuring cultural and linguistic appropriateness for use in older adults in Turkey. Frailty Assessment Instruments 1\. FRAIL Scale (Score Range: 0-5) The FRAIL scale includes five items (Fatigue, Resistance, Ambulation, Illness, and Loss of weight). Each item scores 1 point for "Yes" and 0 points for "No": Fatigue: Feeling tired most or all of the time Resistance: Difficulty climbing 10 steps Ambulation: Difficulty walking one block Illness: Having ≥5 chronic illnesses Loss of Weight: Unintentional weight loss ≥5% in the past 6 months Interpretation: 0 points: Robust 1-2 points: Pre-frail 3-5 points: Frail 2\. FiND Questionnaire (Score Range: 0-5) The FiND tool distinguishes frailty from mobility disability and includes five dichotomous questions: Mobility Items: Inability to walk 400 meters Inability to climb one flight of stairs Frailty Items: Unintentional weight loss Persistent fatigue Reduction in physical activity Interpretation: 0: Normal 1-2: Mild frailty or early disability 3-5: Frailty or mobility disability Frailty assessments were conducted at baseline, mid-treatment (\~3 months), and end of treatment (\~6 months). Nutritional status was assessed with the Mini Nutritional Assessment-Short Form (MNA-SF), performance status with ECOG, and comorbidity burden with the modified Charlson Comorbidity Index (mCCI). CTCAE v5.0 Toxicity Assessment Chemotherapy-related adverse events were systematically recorded at each treatment cycle according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, focusing on clinically relevant toxicities frequently observed during fluoropyrimidine-based adjuvant chemotherapy. Hematologic Toxicities Neutropenia Febrile neutropenia Anemia Thrombocytopenia Gastrointestinal Toxicities Nausea / vomiting Diarrhea Constipation Mucositis / stomatitis Neurologic Toxicities Peripheral sensory neuropathy (oxaliplatin-related) Constitutional Toxicities Fatigue Weight loss Decreased appetite Dermatologic Toxicities Hand-foot syndrome (capecitabine-related) Rash Laboratory Abnormalities Elevated liver enzymes Renal function changes Toxicity Grading Toxicities were graded on a 5-point scale: Grade 1-2: Mild to moderate Grade 3: Severe, medically significant Grade 4: Life-threatening Grade 5: Treatment-related death The primary endpoint was the incidence of Grade ≥3 toxicity. Secondary analyses explored dose delays, treatment reductions, early discontinuation, and associations between frailty dynamics and toxicity patterns. Study Objective and Rationale The study aimed to determine whether short, rapid frailty screens can help predict chemotherapy tolerance in older adults. Identifying patients at higher risk of toxicity may allow clinicians to personalize treatment intensity, optimize supportive care, and avoid unnecessary harm. This research contributes real-world evidence supporting the integration of frailty screening into routine oncology practice.

Conditions

• Gastrointestinal Cancers
• Frailty at Older Adults
• Chemotherapy

Interventions

Type	Name	Description
OTHER	No Intervention	This study assigned no intervention. Participants received standard-of-care adjuvant chemotherapy according to routine clinical oncology practice. The study observed frailty assessments and toxicity outcomes only.

Timeline

• Start date: 2023-12-20
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2025-12-09
• Last updated: 2025-12-18

Locations

1 site across 1 country: Turkey (Türkiye)