Malignant Tumor of Head and/or Neck, Radiotherapy; Complications
Conditions
Brief 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
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.
Interventions
OTHERSystematic oral health education
Provide systematic oral health education to patients in experimental group, including oral hygiene instruction and dietary instruction
OTHERRoutine oral health education
Provide routine oral health education to patients in control group, including routine oral self-care instruction
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Intervention group: Systematic oral health education Control group: Routine oral health education
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of oral mucositis (OM) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of severe oral mucositis (SOM) (WHO grade ≥3) | 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 |
| The time to onset of severe oral mucositis (SOM) (WHO grade ≥3) | 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy | Time from the first day of radiotherapy to the first determination of SOM. |
| The duration of severe oral mucositis (WHO grade ≥3) | 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy | The first determination of SOM to the first instance of non-severe OM (WHO grade \<3), without a subsequent instance of SOM. |
| The time to onset of any-grade oral mucositis (OM) | 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy | Time from the first day of radiotherapy to the first determination of OM. |
| The duration of any-grade oral mucositis (OM) | 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy | The first determination of OM to the first instance of non-OM, without a subsequent instance of OM. |
Countries
China
Outcome results
None listed