NCT05937477

Developing Artificial Intelligence-based Algorism to Predict Side Effects and Symptoms From Chemotherapy

Developing Artificial Intelligence-based Algorism Based on Life-log Data Acquired From Wearable Device for the Prediction of Chemotherapy-induced Side Effects and Symptom

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Sehhoon Park · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators obtain wearable disease based biomarkers from patients diagnosed with cancer and undergoing chemotherapy, and simultaneously measure patient self-reported adverse events through an app to evaluate chemotherapy completion rates, emergency room visits, and frequency of CTCAE adverse events. The investigators will develop an artificial intelligence-based algorism that can predict patients' side effects based on biomarkers alone.

Detailed description

In this study, patients diagnosed with lung, head and neck, and esophageal cancers and undergoing chemotherapy will be measured for self-reported side effects using a wearable device to collect biomarkers through an app, and the association between patient quality of life and side effects and biomarkers obtained from the wearable device will be analyzed. On the other hand, blood (EDTA 3cc) for pharmacogenomics testing will be tested once at any point during the study period as an indicator associated with side effects after chemotherapy.

Conditions

• Lung Cancer
• Head and Neck Cancer
• Esophageal Cancer

Interventions

Type	Name	Description
OTHER	Fitbit smartwatch	Patients wear the wearable to check their biomarkers and use the application to assess their quality of life and side effects at one-week intervals.

Timeline

• Start date: 2023-06-08
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2023-07-10
• Last updated: 2023-07-21

Locations

1 site across 1 country: South Korea