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

Sponsor

Sehhoon Park (Other)

Overall Status

Recruiting

CT.gov ID

NCT05937477

Collaborator

(none)

500

Enrollment

Location

36.7

Anticipated Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Head and Neck Cancer Esophageal Cancer	Other: Fitbit smartwatch

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 8, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Neoadjuvant, Adjuvant Chemotherapy Arm Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Neoadjuvant, Adjuvant chemotherapy.	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.
Palliative Chemotherapy Arm Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Palliative chemotherapy.	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.

Arm

Intervention/Treatment

Neoadjuvant, Adjuvant Chemotherapy Arm

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

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.

Palliative Chemotherapy Arm

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

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.

Outcome Measures

Primary Outcome Measures

Developing artificial intelligence prediction algorism [Through study completion, an average of 30.0 mounth]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

20 years of age or older
Must have diagnosed with lung, head and neck, or esophageal cancer,

scheduled to receive their first treatment in preoperative or postoperative chemotherapy.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul	Gangnamgu	Korea, Republic of	06351

Sponsors and Collaborators

Sehhoon Park

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sehhoon Park, M.D, Ph.D. Principal Investigator, Clinical Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT05937477

Other Study ID Numbers:

2023-02-057

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 10, 2023