Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Frailty at Older Adults | — | UNRESOLVED | — |
| Gastrointestinal Cancers | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adjuvant Chemotherapy Cohort
- description
- 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.
- interventionNames
- Other: No Intervention
Primary outcomes (1)
- measure
- Association Between Baseline Frailty Scores (FRAIL and FiND) and the Incidence of Grade ≥3 Chemotherapy-Related Toxicity
- timeFrame
- 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).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥65 years * Histologically confirmed gastrointestinal (GI) malignancy, including: Colorectal adenocarcinoma (colon or rectum), Gastric adenocarcinoma, Pancreatic adenocarcinoma, Biliary tract cancer (cholangiocarcinoma, gallbladder cancer) Small intestine adenocarcinoma, Esophageal cancer (adenocarcinoma or squamous cell carcinoma) * Completion of curative-intent surgery with a postoperative plan for adjuvant chemotherapy. * Receipt of standard adjuvant chemotherapy, including (but not limited to): FOLFOX, CAPOX (XELOX), Capecitabine monotherapy, FOLFIRINOX (selected fit older adults only), Gemcitabine ± capecitabine * Initiation of adjuvant chemotherapy within the study period. * Baseline frailty assessment (FRAIL Scale and FiND questionnaire) completed before the first chemotherapy cycle. * Ability to provide informed consent and comply with frailty and toxicity follow-up assessments. Exclusion Criteria: * Age \<65 years. * Metastatic, recurrent, or unresectable disease at the time of adjuvant treatment. * Receiving neoadjuvant-only treatment without subsequent adjuvant chemotherapy. * Non-adenocarcinoma GI malignancies treated with protocols outside standard adjuvant chemotherapy (e.g., GIST receiving adjuvant imatinib; neuroendocrine tumors). * Prior chemotherapy within 12 months for another malignancy. * Missing baseline frailty assessment (FRAIL or FiND). * Missing toxicity follow-up after chemotherapy initiation. * Severe cognitive impairment, advanced dementia, or psychiatric illness preventing reliable questionnaire completion. * Concurrent participation in another interventional clinical trial that may alter chemotherapy toxicity or functional outcomes.
References
Publications (0)
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