A Randomized Controlled Study on the Improvement of Medical Experience for Patients With Radiation-induced Oropharyngeal Mucositis Based on the RIS System of the Internet of Things

NCT ID: NCT07126457

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-12-01

Brief Summary

This study is a researcher-initiated, multi-center, prospective, two-arm interventional randomized controlled study across the country. It aims to explore whether an Internet of Things-based RIS system can enhance the medical experience of patients with radiation-induced oropharyngeal mucositis during the diagnosis and treatment process among head and neck cancer patients undergoing radiotherapy.

Detailed Description

After signing the informed consent form, patients who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to the experimental group (using the RIS system group) and the control group (not using the RIS system group), with a total of 110 patients recruited.

Subjects randomized to the experimental group will be managed and followed up using the RIS system based on Internet of Things technology from the start of radiotherapy until one year after radiotherapy.

Subjects randomized to the control group will be treated and followed up using the current clinical routine management model.

The treatment period refers to the time from the start of radiotherapy to one month after the end of radiotherapy. During this period, patients are treated according to the standard treatment methods for head and neck malignancies (concurrent chemoradiotherapy, induction chemotherapy followed by concurrent chemoradiotherapy, or radiotherapy alone, chemotherapy alone). In the experimental group, the RIS system is used for auxiliary management. After the start of radiotherapy, the three modules of the system (one-way output module, two-way interaction module, and public science popularization module) are used to manage patients until the end of the treatment period. The one-way output module management mainly transmits information to patients through the database, providing them with relevant suggestions such as precautions and psychological counseling. The two-way interaction module management mainly conducts interactive information exchange through artificial intelligence programs, providing patients with personalized and real-time life advice or precautions. The public science popularization module conducts science popularization education for the public and patients through popular science works.

Conditions

Head and Neck Cancer; Radiation-Induced Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

experimental group

Use the RIS system

Group Type: EXPERIMENTAL

RIS system

Intervention Type: OTHER

The RIS system based on the Internet of Things consists of three aspects: one-way output management of the large database of head and neck tumors, two-way interaction management of artificial intelligence applications, and popular science dissemination for the general public.

control group

Do not use the ris system

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RIS system

The RIS system based on the Internet of Things consists of three aspects: one-way output management of the large database of head and neck tumors, two-way interaction management of artificial intelligence applications, and popular science dissemination for the general public.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Voluntarily sign the informed consent form;

2. Reached the age of 18 on the date of signing the informed consent form, and under the age of 65;

3. Patients diagnosed with head and neck tumors and receiving radiotherapy as per the 2017 WHO standards and guidelines.

4. According to the doctor's assessment, patients may experience radiation-induced oropharyngeal mucositis during radiotherapy.

Exclusion Criteria

• Have other uncontrolled serious diseases, such as unstable heart diseases requiring treatment, poorly controlled diabetes (fasting blood sugar > 1.5 times the upper limit of the normal value), mental disorders, and a severe history of allergies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Guan, M.D

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China

Huizhou Central People's Hospital

Huizhou, Guangdong, China

Jieyang people's hospital

Jieyang, Guangdong, China

Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou

Meizhou, Guangdong, China

Countries

China

Central Contacts

Jian Guan, M.D

Role: CONTACT

guanjian5461@163.com

+86-13632102247

Other Identifiers

NFEC-2025-231

Identifier Type: -

Identifier Source: org_study_id