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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788499
• Other study ID #: XQonc-009
• Status: Completed
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: February 2024
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Mucositis
• Nasopharyngeal Carcinoma
• Stomatitis

Intervention

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.

Locations

Country	Name	City	State
China	the second affiliated hospital of Army medical university	Chongqing	Chongqing
China	Xinqiao Hospital of Chongqing	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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