AI-Assisted Chemotherapy Side Effect Management

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Colorectal Cancer

In brief

This two-stage adaptive randomized controlled trial evaluates the feasibility and preliminary efficacy of large language model (LLM)-assisted intervention for managing chemotherapy side effects in patients with solid tumors. Adults with histologically confirmed breast or colorectal cancer scheduled for at least 3 months of systemic chemotherapy will be randomly assigned (1:1) to receive either LLM-assisted care or standard care. The study employs an adaptive design with initial enrollment of 60 patients (30 per arm), followed by interim analysis. Unless enrollment is stopped for safety reasons identified at interim analysis, an additional 114 patients will be enrolled for a maximum total of 174 patients (87 per arm). In the intervention group, healthcare providers input anonymized patient symptom data into an LLM system using sessions where data is not retained, which generates evidence-based management recommendations. Physicians critically review these recommendations and use them as reference for clinical decision-making, with final treatment decisions remaining under physician discretion. The control group receives standard supportive care without LLM assistance. The primary outcome is change in health-related quality of life measured by EORTC QLQ-C30 global health status/QoL scale from baseline to end of treatment. Secondary outcomes include proportion achieving clinically meaningful improvement (≥8-point increase), treatment adherence, dose intensity, healthcare resource utilization, and physician acceptance of LLM recommendations.

Key facts

Study ID

NCT07198581

Run by

Incheon St.Mary's Hospital

People needed

174

Starts

2025-11-12

Expected to finish

2026-10-31

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (≥ 18 years old) diagnosed with histologically confirmed solid malignancies (breast cancer, colorectal cancer)
• Patients scheduled to receive at least 3 months of systemic chemotherapy
• ECOG performance status 0-2

You may not qualify if…

• Severe psychiatric disorders
• Cognitive impairment affecting ability to report symptoms
• Presence of cancer-related symptoms prior to chemotherapy initiation
• Concurrent participation in trials evaluating other symptom management interventions Inability to provide informed consent Life expectancy less than 6 months

Where it is running

• Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea — Incheon, South Korea (enrolling)

Full record on ClinicalTrials.gov

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