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

NCT03788499 | Completed

• 1 other identifier: XQonc-009
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Massage; Maxillofacial and Oral Cavity; Radioactive Oral Mucositis; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.

  3 months

Study Arms (2)

Control arm

NO INTERVENTION

routine oral care and functional exercise.

Massage arm

EXPERIMENTAL

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

Other: Massage of Maxillofacial and Oral Cavity

Interventions

Massage of Maxillofacial and Oral Cavity OTHER

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.

Massage arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (2)

Xinqiao Hospital of Chongqing

Chongqing, Chongqing Municipality, 400000, China

Location

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 40037, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: December 27, 2018
• Study Start: January 11, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CN (2)