AI-assisted support for side effects of chemotherapy in breast or colorectal cancer
Tests AI-assisted management of chemotherapy side effects in adults with breast or colorectal cancer.
Plain-language title generated from the registry record
Registry title: AI-Assisted Chemotherapy Side Effect Management
Key facts
- Where
- Incheon, South KoreaSee the site
Where in South Korea
- Incheon St. Mary's Hospital, College of Medicine, The Catholic University of KoreaIncheon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Incheon St.Mary's Hospital
- Trial code
- NCT07198581
- Record updated
- 22 April 2026
- Original description
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.Read full original descriptionShow less
A Randomized Controlled Trial of AI-Assisted Chemotherapy Side Effect Management in Solid Tumor Patients
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.
Inclusion: 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.
Exclusion: 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; Severe psychiatric disorders; Cognitive impairment affecting ability to report symptoms.