Clinical trial NCT03788499: Using Massage of Maxillofacial and Oral Cavity to Prevent Radioactive Oral Mucositis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: Massage
Maxillofacial and Oral Cavity
Radioactive Oral Mucositis
Nasopharyngeal Carcinoma
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of severe radioactive oral mucositis
timeFrame: 3 months
Secondary outcomes:
measure: the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.
timeFrame: 3 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Xinqiao Hospital of Chongqing
state: Chongqing
city: Chongqing
country: China
facility: the second affiliated hospital of Army medical university
state: Chongqing
Study officials:
References: