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

Sehhoon Park

Status: Enrolling

Conditions: Esophageal Cancer; Lung Cancer; Head and Neck Cancer

Treatments: Other: Fitbit smartwatch

Study type: Observational

Funder types: Other

Identifiers

NCT05937477

2023-02-057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Neoadjuvant, Adjuvant Chemotherapy Arm

Description:

Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Neoadjuvant, Adjuvant chemotherapy.

Treatment:

Other: Fitbit smartwatch

Palliative Chemotherapy Arm

Description:

Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Palliative chemotherapy.

Treatment:

Other: Fitbit smartwatch