Clinical trial · Interventional
AI-Assisted Chemotherapy Side Effect Management
A Randomized Controlled Trial of AI-Assisted Chemotherapy Side Effect Management in Solid Tumor Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LLM-assisted chemotherapy side effect management | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LLM Intervention Group
- description
- 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.
- interventionNames
- Behavioral: LLM-assisted chemotherapy side effect management
- type
- NO_INTERVENTION
- label
- Standard Care Group
- description
- Patients receive standard chemotherapy with conventional symptom management based on institutional protocols and physician clinical judgment.
Primary outcomes (1)
- measure
- Change in health-related quality of life measured by EORTC QLQ-C30 global health status/QoL scale (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 - Global Health Status/Quality of Life Scale)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available