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

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: Nasopharyngeal Carcinoma
• Intervention / Treatment: Other: Massage of Maxillofacial and Oral Cavity

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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.	the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.	3 months

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing

Study record dates

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: Massage; Nasopharyngeal Carcinoma; Maxillofacial and Oral Cavity; Radioactive Oral Mucositis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Gastroenteritis; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Mucositis; Stomatitis
• 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