Clinical trial NCT06690346: Systematic Oral Education for Prevention of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer
Official title: A Single-center, Phase II Clinical Trial of Systematic Oral Education for the Prevention of Oral-related Complications Caused by Radiotherapy for Head and Neck Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Tumor of Head And/or Neck
Radiotherapy; Complications
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: West China Fourth Hospital, Sichuan University
First posted: 2024-11-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: Systematic oral health education Control group: Routine oral health education
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Oral mucositis
timeFrame: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 3, 6, 12 months after the end of radiotherapy
Secondary outcomes:
measure: Xerostomia
timeFrame: 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
measure: Dysphagia
timeFrame: 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
measure: Quality of Life assessed by EORTC QLQ-C30
timeFrame: 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
measure: Quality of Life assessed by QLQ-H&N35
timeFrame: 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
measure: Number of teeth
timeFrame: 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
measure: Periodontal pocket depth
timeFrame: 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
measure: Bleeding on probing
timeFrame: 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
measure: Plaque
timeFrame: 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
measure: Adverse effects
timeFrame: up to 12 months
measure: Changes of oral flora
timeFrame: 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
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: