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NCT Number: NCT03788499

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinqiao Hospital of Chongqing, Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of severe radioactive oral mucositis

    Time frame: 3 months

    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 outcomes

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

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

Randomized, Controlled Clinical Study of Using Massage of Maxillofacial and Oral Cavity to Prevent Oral Mucositis in Patients With Nasopharyngeal Carcinoma Undergoing Radiotherapy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 27, 2018
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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