Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788499
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Jianguo Sun, Xinqiao Hospital of Chongqing

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.


Layout table for study information
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
Estimated Study Start Date : January 4, 2019
Estimated Primary Completion Date : November 27, 2019
Estimated Study Completion Date : February 26, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Layout table for additonal information
Responsible Party: Jianguo Sun, Professor, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT03788499     History of Changes
Other Study ID Numbers: XQonc-009
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Layout table for additional information
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:
Layout table for MeSH terms
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