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

NCT ID: NCT06690346

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-26

Study Completion Date

2025-06-26

Brief Summary

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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

Detailed Description

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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.

Conditions

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Malignant Tumor of Head and/or Neck Radiotherapy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group: Systematic oral health education Control group: Routine oral health education
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental group

Systematic oral health education

Group Type EXPERIMENTAL

Systematic oral health education

Intervention Type OTHER

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

Control group

Routine oral health education

Group Type OTHER

Routine oral health education

Intervention Type OTHER

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

Interventions

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Systematic oral health education

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

Intervention Type OTHER

Routine oral health education

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xingchen Peng

Study director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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2024-1262

Identifier Type: -

Identifier Source: org_study_id