Malignant Tumor of Head and/or NeckNCT06690346
Systematic Oral Education for Prevention of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer
A study testing Systematic oral health education and Routine oral health education in people with Malignant Tumor of Head and/or Neck and Radiotherapy; Complications, run by West China Hospital at 1 site in China.
Trial summary
A study on the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Tumor of Head and/or Neck, Radiotherapy; Complications
- What is being tested?
- Systematic oral health education and Routine oral health education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2024to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with malignant tumors of the head and neck without metastasis
- Age ≥18, ≤80 years old
- ECOG_PS score ≤2
- Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of >50 Gy
- Signed informed consent form
Who cannot join
- Patients with oral mucositis due to allergic reactions to certain foods, medications, or oral care products
- Have a history of head and neck radiotherapy
- Poor oral hygiene or severe periodontitis
- Poor compliance
- Other patients who, in the opinion of the investigator, are not suitable for participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systematic Oral Care Education for Preventing Oral Complications in Patients Undergoing Radiotherapy for Head and Neck Malignancies: A Randomized Controlled Trial
A study on the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors
Read the detailed description
The goal of this clinical trial is to investigate the efficacy of systematic oral health education for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main question it aims to answer is:
the efficacy of systematic oral health education for the prevention oral-related complications caused by radiotherapy for head and neck malignant tumors
Participants will:
be given systematic oral health education or routine oral health education be evaluated to learn the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors Researchers will compare systematic oral health education group with routine oral health education group to see if systematic oral health education has good efficacy for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors.
- Being tested
- Systematic oral health education, Routine oral health education
- 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.
Systematic oral health educationOther
Provide systematic oral health education to patients in experimental group, including oral hygiene instruction and dietary instruction
Routine oral health educationOther
Provide routine oral health education to patients in control group, including routine oral self-care instruction
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Systematic oral health education Receives: Other: Systematic oral health education |
| Control group | Other | Routine oral health education Receives: Other: Routine oral health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of oral mucositis (OM)
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale(grade 1-5); Higher grade indicates more severe symptoms
Measured: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
Secondary outcomes (5)
The incidence of severe oral mucositis (SOM) (WHO grade ≥3)
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale(grade 1-5); Higher grade indicates more severe symptoms
Measured: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
The time to onset of severe oral mucositis (SOM) (WHO grade ≥3)
Time from the first day of radiotherapy to the first determination of SOM.
Measured: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
The duration of severe oral mucositis (WHO grade ≥3)
The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM.
Measured: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
The time to onset of any-grade oral mucositis (OM)
Time from the first day of radiotherapy to the first determination of OM.
Measured: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
The duration of any-grade oral mucositis (OM)
The first determination of OM to the first instance of non-OM, without a subsequent instance of OM.
Measured: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start26 Nov 2024
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumor of Head and/or NeckStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: Systematic oral health education Control group: Routine oral health education
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690346
- Sponsor's protocol ID
- 2024-1262
- Status last verified
- Jun 2026
- First submitted
- 8 Nov 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Oral Care Education for Preventing Oral Complications in Patients Undergoing Radiotherapy for Head and Neck Malignancies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06690346
- Acronym / sponsor ID
- 2024-1262
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 15 Nov 2024 (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.
A study on the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors
Detailed description
The goal of this clinical trial is to investigate the efficacy of systematic oral health education for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main question it aims to answer is:
the efficacy of systematic oral health education for the prevention oral-related complications caused by radiotherapy for head and neck malignant tumors
Participants will:
be given systematic oral health education or routine oral health education be evaluated to learn the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors Researchers will compare systematic oral health education group with routine oral health education group to see if systematic oral health education has good efficacy for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group: Systematic oral health education Control group: Routine oral health education
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Systematic oral health educationSystematic oral health education |
| Control group | Other | Other: Routine oral health educationRoutine oral health education |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with malignant tumors of the head and neck without metastasis
- Age ≥18, ≤80 years old
- ECOG_PS score ≤2
- Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of >50 Gy
- Signed informed consent form
Key exclusion criteria (5 listed)
- Patients with oral mucositis due to allergic reactions to certain foods, medications, or oral care products
- Have a history of head and neck radiotherapy
- Poor oral hygiene or severe periodontitis
- Poor compliance
- Other patients who, in the opinion of the investigator, are not suitable for participation in this study
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 |
|---|---|---|
| Systematic oral health educationProvide systematic oral health education to patients in experimental group, including oral hygiene instruction and dietary instruction | Other | Experimental group |
| Routine oral health educationProvide routine oral health education to patients in control group, including routine oral self-care instruction | Other | Control group |
Primary outcome
The incidence of oral mucositis (OM)
Time frame: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale(grade 1-5); Higher grade indicates more severe symptoms
5 secondary outcomes
The incidence of severe oral mucositis (SOM) (WHO grade ≥3)
Time frame: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
The time to onset of severe oral mucositis (SOM) (WHO grade ≥3)
Time frame: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
The duration of severe oral mucositis (WHO grade ≥3)
Time frame: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
The time to onset of any-grade oral mucositis (OM)
Time frame: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
The duration of any-grade oral mucositis (OM)
Time frame: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic oral health education and Routine oral health education in people with Malignant Tumor of Head and/or Neck and Radiotherapy; Complications, run by West China Hospital at 1 site 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of oral mucositis (OM) (time frame: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy). 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 29 Jun 2026.