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

Recruiting

• Conditions: Head and Neck Cancer; Esophageal Cancer; Lung Cancer
• Interventions: Other: Fitbit smartwatch

• Registration Number: NCT05937477
• Lead Sponsor: Sehhoon Park

Brief 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.

Study Timeline

• Study Start: 2023-06-08
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-30
• Status Verified: 2023-07
• Study First Posted: 2023-07-10
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 20 years of age or older

• Must have diagnosed with lung, head and neck, or esophageal cancer,

  1. scheduled to receive their first treatment in preoperative or postoperative chemotherapy.
  2. scheduled for systemic chemotherapy due to recurrence or metastasis.

• Eastern Cooperative Oncology (ECOG) performance status of 0 to 2.

• Patients who have access to a smartphone and can use the mobile app on their own.

• Understand the purpose of the study and agree to participate in the study.

Exclusion Criteria

• Patients who, in the judgment of the researcher, have difficulty using the application.
• Patients who are judged by the medical staff to be unable to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant, Adjuvant Chemotherapy Arm	Fitbit smartwatch	Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Neoadjuvant, Adjuvant chemotherapy.
Palliative Chemotherapy Arm	Fitbit smartwatch	Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Palliative chemotherapy.

Primary Outcome Measures

Name	Time	Method
Developing artificial intelligence prediction algorism	Through study completion, an average of 30 months	PRO data and treatment information collected from the wearable are used to evaluate correlations through methods such as linear regression to determine valid variables, utilizing LSTM models, etc.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gangnamgu, Korea, Republic of