Systematic Oral Education for Prevention of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer

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

Study Overview

• Status: Completed
• Conditions: Radiotherapy; Complications; Malignant Tumor of Head and/or Neck
• Intervention / Treatment: Other: Systematic oral health education; Other: Routine oral health education

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Systematic oral health education	Other: Systematic oral health education; Provide systematic oral health education to patients in experimental group, including oral hygiene instruction and dietary instruction
Other: Control group; Routine oral health education	Other: Routine oral health education; Provide routine oral health education to patients in control group, including routine oral self-care instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: West China Fourth Hospital, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 2024-1262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No