A Randomized Controlled Trial of AI-Assisted Chemotherapy Side Effect Management in Solid Tumor Patients

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 40 patients (20 per arm), followed by interim analysis. If predefined criteria are met, an additional 134 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea
RECRUITING
Incheon
Contact Information
Primary
Young-Joon Kang
yjkang.md@gmail.com
+82322805179
Time Frame
Start Date: 2025-11-12
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 174
Treatments
Experimental: LLM Intervention Group
Patients receive standard chemotherapy with AI-assisted symptom management. Healthcare providers input anonymized patient symptoms into a large language model system during clinic visits. The LLM generates management recommendations that physicians review and consider for treatment decisions.
No_intervention: Standard Care Group
Patients receive standard chemotherapy with conventional symptom management based on institutional protocols and physician clinical judgment.
Related Therapeutic Areas
Sponsors
Leads: Incheon St.Mary's Hospital

This content was sourced from clinicaltrials.gov