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

West China Hospital150 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

150

Conditions

Malignant Tumor of Head and/or Neck Radiotherapy; Complications

Interventions

Systematic oral health educationOTHER

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

Routine oral health educationOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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