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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Systematic oral health education |
|
| Control group | Other | Routine oral health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systematic oral health education | Other | Provide systematic oral health education to patients in experimental group, including oral hygiene instruction and dietary instruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of oral flora | The changes of oral flora in patients' salivary or oral swab measured by 16s rDNA technique | 1 week before radiotherapy; at the middle of radiotherapy(3 weeks after the start of radiotherapy); at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks). |
| Xerostomia |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | China |
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Intervention group: Systematic oral health education Control group: Routine oral health education
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| Routine oral health education | Other | Provide routine oral health education to patients in control group, including routine oral self-care instruction |
|
| 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. | 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. | 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. | 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. | 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy |
Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms |
| 1 week before radiotherapy; at the middle of radiotherapy(3 weeks after the start of radiotherapy); at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); 1, 2, 3 months after the end of radiotherapy |
| Quality of Life assessed by EORTC QLQ-C30 | Quality of Life is assessed by EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire);transformed into 0-100 scales for different domains and symptoms;Higher domain scores represent better quality of life, while higher symptom scores represent worse quality of life | 1 week before radiotherapy; at the middle of radiotherapy(3 weeks after the start of radiotherapy); at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); 1, 2, 3 months after the end of radiotherapy |
| Quality of Life assessed by QLQ-H&N35 | Quality of Life is assessed by QLQ-H&N35(Head and neck cancer-related quality of life scale);transformed into 0-100 scales for different domains and symptoms;Higher scores represent worse quality of life | 1 week before radiotherapy; at the middle of radiotherapy(3 weeks after the start of radiotherapy); at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); 1, 2, 3 months after the end of radiotherapy |
| Dysphagia | Dysphagia is assessed by M.D.Anderson Dysphagia Inventory(score 20-100);Lower score indicates more severe symptoms | 1 week before radiotherapy; at the middle of radiotherapy(3 weeks after the start of radiotherapy); at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); 1, 2, 3 months after the end of radiotherapy |
| The number of dental specialist visits | The number of dental specialist visits during radiotherapy between two groups | The time period is the period from the start of radiotherapy to the completion of radiotherapy (usuallly 6 or 6.5 weeks). |
| Oral health status | Oral health status encompasses several key variables: the number of natural teeth, teeth with caries, periodontal pockets, gingival bleeding, clinical attachment loss, plaque index (mean ± SD), and limited mouth opening (abnormal). | 1 week before radiotherapy; at the middle of radiotherapy(3 weeks after the start of radiotherapy); at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); 1, 2, 3months after the end of radiotherapy |
| Radiotherapy interruption rate | The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy. | 1 week before radiotherapy; at the middle of radiotherapy(3 weeks after the start of radiotherapy); at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks). |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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