Skip to main content
OpenTrials
Completed

NCT Number: NCT06690346

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Tumor of Head and/or Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiotherapy; Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systematic oral health education

Other

Provide systematic oral health education to patients in experimental group, including oral hygiene instruction and dietary instruction

Routine oral health education

Other

Provide routine oral health education to patients in control group, including routine oral self-care instruction

Primary outcomes

  1. The incidence of oral mucositis (OM)

    Time frame: 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 outcomes

  1. The incidence of severe oral mucositis (SOM) (WHO grade ≥3)

    Time frame: 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

  2. The time to onset of severe oral mucositis (SOM) (WHO grade ≥3)

    Time frame: 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.

  3. The duration of severe oral mucositis (WHO grade ≥3)

    Time frame: 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.

  4. The time to onset of any-grade oral mucositis (OM)

    Time frame: 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.

  5. The duration of any-grade oral mucositis (OM)

    Time frame: 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.

Other outcomes

  1. Changes of oral flora

    Time frame: 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).

    The changes of oral flora in patients' salivary or oral swab measured by 16s rDNA technique

  2. Xerostomia

    Time frame: 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

    Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms

  3. Quality of Life assessed by EORTC QLQ-C30

    Time frame: 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 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

  4. Quality of Life assessed by QLQ-H&N35

    Time frame: 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 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

  5. Dysphagia

    Time frame: 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 is assessed by M.D.Anderson Dysphagia Inventory(score 20-100);Lower score indicates more severe symptoms

  6. The number of dental specialist visits

    Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy (usuallly 6 or 6.5 weeks).

    The number of dental specialist visits during radiotherapy between two groups

  7. Oral health status

    Time frame: 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

    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).

  8. Radiotherapy interruption rate

    Time frame: 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).

    The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Systematic Oral Care Education for Preventing Oral Complications in Patients Undergoing Radiotherapy for Head and Neck Malignancies: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.