Using Massage of Maxillofacial and Oral Cavity to Prevent Radioactive Oral Mucositis
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|ClinicalTrials.gov Identifier: NCT03788499|
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Other: Massage of Maxillofacial and Oral Cavity||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||January 4, 2019|
|Estimated Primary Completion Date :||November 27, 2019|
|Estimated Study Completion Date :||February 26, 2020|
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.
- Incidence of severe radioactive oral mucositis [ Time Frame: From the first day of radiotherapy to 3 months after the end of radiotherapy ]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.
- the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth. [ Time Frame: From the first day of radiotherapy to 3 months after the end of radiotherapy ]the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.