AI-guided management of chemotherapy side effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-stage, adaptive randomized trial comparing LLM-assisted symptom management to standard care in adults with histologically confirmed breast or colorectal cancer starting at least three months of systemic chemotherapy. In stage 1, 60 patients (30 per arm) will be enrolled with an interim analysis, and unless stopped for safety an additional 114 patients will be added for a maximum of 174 participants (87 per arm). In the intervention arm, clinicians enter anonymized symptom data into an LLM session that does not retain data and receive evidence-based management recommendations which physicians then review and apply as appropriate. The control arm receives usual supportive care, and outcomes will focus on feasibility and preliminary effects on symptom control and related care processes.

Why it matters

Who can join: the full rules

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

Where it's running

• Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea
  Incheon, South Korea Recruiting

Study contacts

• Study coordinator: Young-Joon Kang
• Email: yjkang.md@gmail.com
• Phone: +82322805179

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.