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

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ClinicalTrials.gov Identifier: NCT03788499

Recruitment Status : Unknown

Verified January 2020 by Jianguo Sun, Xinqiao Hospital of Chongqing.
Recruitment status was: Recruiting

First Posted : December 27, 2018

Last Update Posted : January 14, 2020

Sponsor:

Information provided by (Responsible Party):

Jianguo Sun, Xinqiao Hospital of Chongqing

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nasopharyngeal Carcinoma	Other: Massage of Maxillofacial and Oral Cavity	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	160 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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
Actual Study Start Date :	January 11, 2019
Estimated Primary Completion Date :	February 27, 2021
Estimated Study Completion Date :	February 27, 2021

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Nasopharyngeal Carcinoma

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788499

Locations

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China, Chongqing
Xinqiao Hospital of Chongqing	Recruiting
Chongqing, Chongqing, China, 400000
Contact: Sun Jianguo yanmaizhixiang@sina.cn
Contact 023774490 ext 0086
the second affiliated hospital of Army medical university	Recruiting
Chongqing, Chongqing, China, 40037
Contact: jianguo sun, Phd 023-68774490 sunjg09@aliyun.com

Sponsors and Collaborators

Xinqiao Hospital of Chongqing

More Information

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Responsible Party:	Jianguo Sun, Professor, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier:	NCT03788499
Other Study ID Numbers:	XQonc-009
First Posted:	December 27, 2018 Key Record Dates
Last Update Posted:	January 14, 2020
Last Verified:	January 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Jianguo Sun, Xinqiao Hospital of Chongqing:


Massage Maxillofacial and Oral Cavity Radioactive Oral Mucositis Nasopharyngeal Carcinoma

Additional relevant MeSH terms:

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Carcinoma Nasopharyngeal Carcinoma Mucositis Stomatitis Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Nasopharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms	Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases

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