Using Massage of Maxillofacial and Oral Cavity to Prevent Radioactive Oral Mucositis

February 21, 2024 updated by: Jianguo Sun, Xinqiao Hospital of Chongqing

Randomized, Controlled Clinical Study of Using Massage of Maxillofacial and Oral Cavity to Prevent Oral Mucositis in Patients With Nasopharyngeal Carcinoma Undergoing Radiotherapy

A total of 160 cases of nasopharyngeal carcinoma patients who met the inclusion criteria were randomly assigned to two groups. The experimental group was given massage of maxillofacial and oral cavity plus routine oral care and functional exercise. The control group was given routine oral care and functional exercise. Analyze the difference of incidence of severe acute radioactive oral mucositis in these two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

160 nasopharyngeal carcinoma patients were enrolled and randomly assigned to two groups in a 1:1 ratio. The experimental group was given massage of maxillofacial and oral cavity plus routine oral care and functional exercise, the control group was only given routine oral care and functional exercise. Assess the condition of oral mucosa, according to the grading standard of RTOG acute radiation injury, everyday during radiotherapy. After radiotherapy, follow up the condition of oral mucosa one time per month for a total three times. Then analyze the incidence difference between two groups.

massage method：The duration of the massage lasts from the first day of radiotherapy to three months after the end of radiotherapy，5 times a day（After getting up, before breakfast, lunch, dinner and going to bed). massage of maxillofacial includes the left and right cheeks, the upper jaw, the lower jaw, and around the mouth. Oral Massage includes the tongue, hard palate, the gums, and the bucca. Each part lasts 1-2min，repeating 3 cycles each time. Patients who could finished at least 75% are included in the statistical analysis.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 40037
        • The Second Affiliated Hospital of Army Medical University
      • Chongqing, Chongqing, China, 400000
        • Xinqiao Hospital of Chongqing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients diagnosed by pathology with nasopharyngeal carcinoma;
  2. ECOG PS: 0-2;
  3. Gender is not limited, Age between 18 years old and 70 years old.
  4. Clear consciousness, no mental illness or cognition impairment;
  5. The expected survival time is more than 12 months;

Exclusion Criteria:

  1. Patients with other severe diseases affecting the quality of life or the treatment process;
  2. Unwilling to actively cooperate with investigators;
  3. Patients with previous oral diseases;
  4. Patients who have received head and neck surgery and radiotherapy;
  5. A history of psychotropic substance abuse or a mental disorder;
  6. Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment;
  7. Women who are pregnant or in lactation;
  8. Other situations that may affect the results of the clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
routine oral care and functional exercise.
Experimental: Massage arm
Massage of Maxillofacial and oral cavity plus routine oral care and functional exercise
Other: Massage of Maxillofacial and Oral Cavity
Massage of Maxillofacial and Oral Cavity is performed five times a day, each part lasts 1-2 minutes, repeating 3 cycles. The maxillofacial and oral massage last from the first day of radiotherapy to three months after last radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of severe radioactive oral mucositis
Time Frame: 3 months
the status of oral mucosa was evaluated daily during radiotherapy. According to the grading standard of RTOG acute radiation injury, statistical analysis was made on whether there was a difference and statistical significance in the incidence rate of oral mucositis with radiation above grade 3 between the two groups.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.
Time Frame: 3 months
the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinqiao Hospital of Chongqing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2019

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

July 30, 2020

Study Registration Dates

First Submitted

December 25, 2018

First Submitted That Met QC Criteria

December 25, 2018

First Posted (Actual)

December 27, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XQonc-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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