NCT07198581 AI-Assisted Chemotherapy Side Effect Management
| NCT ID | NCT07198581 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Incheon St.Mary's Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 174 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 174 participants in total. It began in 2025-11-12 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07198581 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07198581 currently recruiting?
Yes, NCT07198581 is actively recruiting participants. Contact the research team at yjkang.md@gmail.com for enrollment information.
Where is the NCT07198581 trial being conducted?
This trial is being conducted at Incheon, South Korea.
Who is sponsoring the NCT07198581 clinical trial?
NCT07198581 is sponsored by Incheon St.Mary's Hospital. The trial plans to enroll 174 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.