Systematic Oral Education for Prevention of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer
- Conditions
- Malignant Tumor of Head And/or NeckRadiotherapy; Complications
- Registration Number
- NCT06690346
- Lead Sponsor
- West China Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Patients diagnosed with malignant tumors of the head and neck without metastasis
- Age ≥18, ≤80 years old
- ZPS score ≤2
- Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of >50 Gy
- Signed informed consent form
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Oral mucositis 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 3, 6, 12 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 Outcome Measures
Name Time Method Xerostomia 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, 3, 6, 12 months after the end of radiotherapy Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms
Quality of Life assessed by QLQ-H&N35 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, 3, 6, 12 months after the end of radiotherapy 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
Number of teeth 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, 3, 6, 12 months after the end of radiotherapy Number of teeth is assessed by trained physicians
Dysphagia 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, 3, 6, 12 months after the end of radiotherapy Dysphagia is assessed by M.D.Anderson Dysphagia Inventory(score 20-100);Lower score indicates more severe symptoms
Quality of Life assessed by EORTC QLQ-C30 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, 3, 6, 12 months after the end of radiotherapy 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
Periodontal pocket depth 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, 3, 6, 12 months after the end of radiotherapy Periodontal pocket depth is assessed by trained physicians using standardized periodontal probes
Bleeding on probing 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, 3, 6, 12 months after the end of radiotherapy Bleeding on probing is assessed by trained physicians using standardized periodontal probes
Plaque 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, 3, 6, 12 months after the end of radiotherapy Plaque is assessed by trained physicians according to Turesky-Modified Quigley-Hein Plaque Index; higher scores represent more plaque
Adverse effects up to 12 months Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version(grade 1-5);Higher grade indicates more severe symptoms
Changes of oral flora 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, 3, 6, 12 months after the end of radiotherapy The changes of oral flora in patients' salivary or oral swab measured by 16s rDNA technique
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China