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

S

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

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

Trial contacts and locations

1

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Central trial contact

Xingchen Peng

Data sourced from clinicaltrials.gov

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