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

NCT07272538 | Completed

• 1 other identifier: AEŞH-EK-2025-125
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Cancers; Frailty at Older Adults; Chemotherapy

Keywords

Geriatric Oncology; Older Adults; Frailty; FRAIL Scale; FIND Questionnaire; Chemotherapy Toxicity; Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

Secondary Outcomes (15)

• Change in FRAIL (Fatigue, Resistance, Ambulation, Illness, Loss of Weight) Scale Score Over Time

  Baseline, 3 months, and 6 months.

• Change in FIND (Frailty and Mobility Disability) Questionnaire Score Over Time

  Baseline, 3 months, and 6 months.

• Correlation Between FRAIL Scale and FIND Questionnaire Scores

  Baseline, 3 months, and 6 months.

• Change in Mini Nutritional Assessment-Short Form (MNA-SF) Score Over Time

  Baseline, 3 months, and 6 months.

• Incidence of Chemotherapy-Related Toxicity Categories Classified by CTCAE Version 5.0

  From first chemotherapy cycle to end of treatment (~6 months).

Study Arms (1)

Adjuvant Chemotherapy Cohort

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

Interventions

No Intervention OTHER

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.

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital Medical Oncology Department

Ankara, Yenimahalle, 06270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: MD

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: December 20, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)