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

Sichuan University

Status: Enrolling

Conditions: Radiotherapy; Complications; Malignant Tumor of Head And/or Neck

Treatments: Other: Routine oral health education; Other: Systematic oral health education

Study type: Interventional

Funder types: Other

Identifiers

NCT06690346

2024-1262

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Experimental group

Experimental group

Description:

Systematic oral health education

Treatment:

Other: Systematic oral health education

Control group

Other group

Description:

Routine oral health education

Treatment:

Other: Routine oral health education