An observational study in Gastrointestinal Cancers, Frailty at Older Adults and Chemotherapy, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Ankara Etlik City Hospital · Observational
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.
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.
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This study's enrollment of 84 is below the median of 197 across 176 observational studies indexed under Gastrointestinal Neoplasms.
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This study included older adults (≥65 years) with gastrointestinal cancers who underwent curative-intent surgery and received standard adjuvant chemotherapy at Ankara Etlik City Hospital. A total of 84 participants were evaluated. All participants completed baseline frailty assessments (FRAIL and FiND) before chemotherapy initiation and were followed throughout the full adjuvant treatment course.
Exclusion Criteria:
This cohort includes older adults (age ≥65 years) with resected gastrointestinal cancers who received standard adjuvant chemotherapy (FOLFOX, CAPEOX, or capecitabine). All participants underwent frailty assessments using the FRAIL and FiND instruments at baseline, mid-treatment, and end of treatment. No intervention was assigned. This group reflects real-world observational follow-up of 84 consecutively treated patients.
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.
Association Between Baseline Frailty Scores (FRAIL and FiND) and the Incidence of Grade ≥3 Chemotherapy-Related Toxicity
This outcome examines whether baseline frailty, analyzed separately using the FRAIL Scale and the FiND Questionnaire, is associated with the development of severe chemotherapy-related toxicity. Toxicities were classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, where Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 = death. Frailty Instruments: FRAIL Scale (Fatigue, Resistance, Ambulation, Illness, Loss of Weight): score range 0-5; higher scores indicate worse frailty. FiND Questionnaire (Frailty and Mobility Disability): score range 0-5; higher scores indicate worse frailty or mobility disability. Each frailty score will be analyzed independently for its association with severe chemotherapy-related toxicity.
Time frame: From baseline (before the first chemotherapy cycle) through every chemotherapy cycle during the adjuvant regimen, with summary toxicity assessments performed at mid-treatment (~3 months) and at treatment completion (~6 months).
Change in FRAIL (Fatigue, Resistance, Ambulation, Illness, Loss of Weight) Scale Score Over Time
The FRAIL Scale ranges from 0 to 5 points, where higher scores indicate worse frailty. This outcome evaluates changes in FRAIL scores at baseline, mid-treatment (3 months), and end of treatment (6 months).
Time frame: Baseline, 3 months, and 6 months.
Change in FIND (Frailty and Mobility Disability) Questionnaire Score Over Time
The FiND Questionnaire ranges from 0 to 5 points, where higher scores indicate worse frailty or mobility disability. This outcome evaluates changes in FiND scores at baseline, 3 months, and 6 months.
Time frame: Baseline, 3 months, and 6 months.
Correlation Between FRAIL Scale and FIND Questionnaire Scores
This outcome evaluates correlations between the FRAIL Scale (0-5; higher = worse frailty) and the FiND Questionnaire (0-5; higher = frailty or mobility disability) at baseline, 3 months, and 6 months.
Time frame: Baseline, 3 months, and 6 months.
Change in Mini Nutritional Assessment-Short Form (MNA-SF) Score Over Time
The MNA-SF ranges from 0 to 14 points, where lower scores indicate worse nutritional status and higher malnutrition risk, whereas higher scores indicate better nutritional status. This outcome measures changes in MNA-SF scores across treatment.
Time frame: Baseline, 3 months, and 6 months.
Incidence of Chemotherapy-Related Toxicity Categories Classified by CTCAE Version 5.0
Chemotherapy-related toxicities were recorded at each cycle and classified using CTCAE v5.0 (Grade 1-5; higher grades indicate more severe toxicity). Categories include hematologic, gastrointestinal, neurologic, dermatologic, constitutional, and laboratory toxicities.
Time frame: From first chemotherapy cycle to end of treatment (~6 months).
Association Between Changes in Frailty Scores and Development of Grade ≥3 Toxicity
This outcome evaluates whether increases in FRAIL score (0-5; higher = worse frailty) between baseline and follow-up (3 and 6 months) are associated with severe toxicity (Grade ≥3).
Time frame: Baseline to 6 months.
Proportion of Participants Completing All Planned Adjuvant Chemotherapy Cycles
Completion is defined as receiving all planned cycles of adjuvant chemotherapy, regardless of dose modifications.
Time frame: End of planned adjuvant chemotherapy (~6 months).
Incidence of Chemotherapy Treatment Modifications
Treatment modifications include any chemotherapy dose reduction, treatment delay, or permanent discontinuation due to toxicity. All modifications were prospectively recorded.
Time frame: From first chemotherapy cycle through the end of treatment (up to 6 months).
Correlation Between FRAIL Scale Score and Eastern Cooperative Oncology Group (ECOG) Performance Status
This outcome examines associations between the FRAIL Scale (0-5; higher = worse frailty) and the ECOG Performance Status (0-5; higher = worse functional capacity) at baseline.
Time frame: Baseline
Correlation Between FRAIL Scale Score and the Modified Charlson Comorbidity Index (mCCI)
This outcome evaluates the association between the FRAIL Scale score and comorbidity burden measured by the Modified Charlson Comorbidity Index (mCCI). FRAIL Scale range: 0-5 points; higher scores indicate worse frailty. mCCI has no fixed upper limit; higher scores indicate greater comorbidity burden. Correlation coefficients will be calculated to determine whether higher frailty scores are associated with higher comorbidity burden.
Time frame: Baseline
Predictive Performance of Baseline FRAIL Score for Grade ≥3 Toxicity
This outcome evaluates the ability of the FRAIL Scale score (0-5; higher = worse frailty) to discriminate between patients who do and do not develop severe toxicity (Grade ≥3), using receiver operating characteristic (ROC) curves and area under the curve (AUC) values.
Time frame: Baseline through 6 months.
Predictive Performance of Baseline FiND Score for Grade ≥3 Toxicity
This outcome evaluates the discriminative ability of the FiND Questionnaire score (0-5; higher = worse frailty or mobility disability) to identify patients who develop Grade ≥3 toxicity, using ROC curves and AUC values.
Time frame: Baseline through 6 months.
Association Between Changes in FIND Questionnaire Score and Development of Grade ≥3 Toxicity
This outcome evaluates whether worsening frailty or mobility limitation, defined as increases in FiND score (0-5), predicts Grade ≥3 chemotherapy-related toxicity.
Time frame: Baseline to 6 months.
Correlation Between FiND Questionnaire Score and Eastern Cooperative Oncology Group (ECOG) Performance Status
This outcome evaluates correlations between the FiND score (0-5; higher = worse frailty or mobility disability) and ECOG status (0-5; higher = worse functional status).
Time frame: Baseline.
Correlation Between FIND Questionnaire Score and the Modified Charlson Comorbidity Index (mCCI)
This outcome evaluates the association between the FiND Questionnaire score and comorbidity burden measured by the Modified Charlson Comorbidity Index (mCCI). FIND Questionnaire range: 0-5 points; higher scores indicate worse frailty or mobility disability. mCCI: higher scores indicate greater comorbidity burden. Correlation coefficients will be calculated to determine whether higher levels of frailty or mobility disability correlate with greater comorbidity burden.
Time frame: Baseline
Plan to share: No — Individual participant data (IPD) will not be shared because the dataset includes sensitive clinical information from older adults and cannot be fully de-identified without compromising data integrity. Data sharing is restricted by institutional ethics board regulations of Ankara Etlik City Hospital. Aggregated results will be made available upon publication.
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