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NCT Number: NCT07126457

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang hospital, Southern medical university, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

Primary outcomes

  1. the satisfaction of patients

    Time frame: Through study completion, up to 3 years

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

Secondary outcomes

  1. The response rate of the processing

    Time frame: Through study completion, up to 3 years

    The proportion of questions raised by the patients that were answered

  2. Evaluation of response validity

    Time frame: Through study completion, up to 3 years

    The effectiveness score of the responses received to the patient's questions

  3. The compliance rate of patients following the recommendations

    Time frame: Through study completion, up to 3 years

    The proportion of patients who followed the response advice and actually carried out the suggested actions

  4. Doctor satisfaction

    Time frame: Through study completion, up to 3 years

    The satisfaction of doctors in the patient management process

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Guan, M.D

CONTACT

[email protected]

+86-13632102247

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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