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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Massage of Maxillofacial and Oral Cavity
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nasopharyngeal Carcinoma focused on measuring Massage, Maxillofacial and Oral Cavity, Radioactive Oral Mucositis, Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xinqiao Hospital of ChongqingRecruiting
  • the second affiliated hospital of Army medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Massage arm

Arm Description

routine oral care and functional exercise.

Massage of Maxillofacial and oral cavity plus routine oral care and functional exercise

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 25, 2018
Last Updated
January 12, 2020
Sponsor
Xinqiao Hospital of Chongqing
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1. Study Identification

Unique Protocol Identification Number
NCT03788499
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
February 27, 2021 (Anticipated)
Study Completion Date
February 27, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Massage, Maxillofacial and Oral Cavity, Radioactive Oral Mucositis, Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
routine oral care and functional exercise.
Arm Title
Massage arm
Arm Type
Experimental
Arm Description
Massage of Maxillofacial and oral cavity plus routine oral care and functional exercise
Intervention Type
Other
Intervention Name(s)
Massage of Maxillofacial and Oral Cavity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of severe radioactive oral mucositis
Description
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.
Time Frame
From the first day of radiotherapy to 3 months after the end of radiotherapy
Secondary Outcome Measure Information:
Title
the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Xinqiao Hospital of Chongqing
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Jianguo
Email
yanmaizhixiang@sina.cn
Phone
023774490
Ext
0086
Facility Name
the second affiliated hospital of Army medical university
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
40037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianguo sun, Phd
Phone
023-68774490
Email
sunjg09@aliyun.com

12. IPD Sharing Statement

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

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