Head and Neck CancerNCT07126457
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
A study testing RIS system in people with Head and Neck Cancer and Radiation-Induced Mucositis, run by Nanfang Hospital, Southern Medical University at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Head and Neck Cancer, Radiation-Induced Mucositis
- What is being tested?
- RIS system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesChina
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, 510515
Huizhou Central People's Hospital
Huizhou, Guangdong, 516000
Jieyang people's hospital
Jieyang, Guangdong, 522000
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Meizhou, Guangdong, 514000
About this study
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.
Read the 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
- Being tested
- RIS system
- Keywords
- Radiation oropharyngeal mucositis, Head and Neck Cancer, Internet of things
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIS systemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Use the RIS system Receives: Other: RIS system |
| control group | No intervention | Do not use the ris system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 3 years
Secondary outcomes (4)
The response rate of the processing
The proportion of questions raised by the patients that were answered
Measured: Through study completion, up to 3 years
Evaluation of response validity
The effectiveness score of the responses received to the patient's questions
Measured: Through study completion, up to 3 years
The compliance rate of patients following the recommendations
The proportion of patients who followed the response advice and actually carried out the suggested actions
Measured: Through study completion, up to 3 years
Doctor satisfaction
The satisfaction of doctors in the patient management process
Measured: Through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Guan, M.D, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126457
- Sponsor's protocol ID
- NFEC-2025-231
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07126457
- Acronym / sponsor ID
- NFEC-2025-231
- Conditions
- Head and Neck Cancer, Radiation-Induced Mucositis
- Keywords
- Radiation oropharyngeal mucositis, Head and Neck Cancer, Internet of things
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: RIS systemUse the RIS system |
| control group | No intervention | –Do not use the ris system |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIS systemThe 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. | Other | experimental group |
Primary outcome
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.
4 secondary outcomes
The response rate of the processing
Time frame: Through study completion, up to 3 years
Evaluation of response validity
Time frame: Through study completion, up to 3 years
The compliance rate of patients following the recommendations
Time frame: Through study completion, up to 3 years
Doctor satisfaction
Time frame: Through study completion, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Guan, M.D principal investigator
Nanfang Hospital, Southern Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIS system in people with Head and Neck Cancer and Radiation-Induced Mucositis, run by Nanfang Hospital, Southern Medical University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Guan, M.D (+86-13632102247, guanjian5461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the satisfaction of patients (time frame: Through study completion, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.