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

NCT06690346 | Completed Phase 3

• 1 other identifier: 2024-1262
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Radiotherapy; Complications; Malignant Tumor of Head and/or Neck

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  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)

  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)

  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)

  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)

  1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy

Other Outcomes (8)

• 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).

• 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, 2, 3 months after the end of radiotherapy

• 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, 2, 3 months after the end of radiotherapy

Study Arms (2)

Experimental group

EXPERIMENTAL

Systematic oral health education

Other: Systematic oral health education

Control group

OTHER

Routine oral health education

Other: Routine oral health education

Interventions

Routine oral health education OTHER

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

Control group

Systematic oral health education OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director

Model Details: Intervention group: Systematic oral health education Control group: Routine oral health education

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 15, 2024
• Study Start: November 26, 2024
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

CN (1)