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

NCT07126457 | Not Yet Recruiting

• 1 other identifier: NFEC-2025-231
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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.

Conditions

Head and Neck Cancer; Radiation-Induced Mucositis

Keywords

Radiation oropharyngeal mucositis; Head and Neck Cancer; Internet of things

Outcome Measures

Primary Outcomes (1)

• the satisfaction of patients

  We use the patient satisfaction scale designed by us for the information age to assess patients' satisfaction during the diagnosis and treatment period.

  Through study completion, up to 3 years

Secondary Outcomes (4)

• The response rate of the processing

  Through study completion, up to 3 years

• Evaluation of response validity

  Through study completion, up to 3 years

• The compliance rate of patients following the recommendations

  Through study completion, up to 3 years

• Doctor satisfaction

  Through study completion, up to 3 years

Study Arms (2)

experimental group

EXPERIMENTAL

Use the RIS system

Other: RIS system

control group

NO INTERVENTION

Do not use the ris system

Interventions

RIS system 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.

experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form;
• Reached the age of 18 on the date of signing the informed consent form, and under the age of 65;
• Patients diagnosed with head and neck tumors and receiving radiotherapy as per the 2017 WHO standards and guidelines.
• According to the doctor's assessment, patients may experience radiation-induced oropharyngeal mucositis during radiotherapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (4)

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, 510515, China

Location

Huizhou Central People's Hospital

Huizhou, Guangdong, 516000, China

Location

Jieyang people's hospital

Jieyang, Guangdong, 522000, China

Location

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

Meizhou, Guangdong, 514000, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jian Guan, M.D

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Guan, M.D

CONTACT

+86-13632102247; guanjian5461@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)