Prevention of Trismus During Radiotherapy and Quality of Life in Head and Neck Cancer Patients

Summary

Trismus (limited jaw mobility), can occur in patients undergoing radiotherapy to specific areas of the head or neck. Trismus leads to difficulty in eating, swallowing, speech and general mouth hygiene, which all have negative effects on quality of life. Research in the area of trismus is limited; it is not known exactly when trismus develops, one study suggests that some patients have experienced a diminished opening at as low doses as 15 Gy. Literature suggests benefits of a training programme, but there is a lack of evidence to support the use of a training programme during radiotherapy.

The purpose of this study is to investigate the effectiveness of a training programme during and after radiotherapy, and report the incidence of trismus in patients who receive radiotherapy to the jaw muscles. The study also investigates quality of life during radiotherapy and up to one year after completed treatment.

Patients who meet the criteria and give their consensus to the study are divided into two groups:

Group 1: Training with TheraBite Jaw Motion Rehabilitation System, which is a portable system utilizing repetitive passive motion and stretching to restore mobility and flexibility of the jaw musculature. Individuals train five times a day.

Group 2: Conventional treatment (jaw measurements once a week). If the individuals jaw mobility decreases 15% from the original start measurement, the patient is automatically offered a trainings program (as in group 1).

During radiation therapy a hospital specialist dentist measures the jaw mobility once a week, thereafter at 3,6,12 months after completed Radiation Therapy. On 5 different occasions the patients are requested to complete a Quality of life questionnaire. Patient's record their training frequency in a log book.

Conditions

• Trismus

Interventions

DEVICE

TheraBite® Jaw Motion Rehabilitation System™

A portable device which utilizes passive motion and stretching to improve mobility and flexibility of the jaw muscles and associated joints. Patients are given written and verbal information about TheraBite before the commencement of Radiotherapy. Investigators instruct on usage and maintenance of TheraBite. Patients are instructed to start a trainings pass by softening the jaw muscles with a simple exercise. The training programme consists of five stretches performed 5 times per day, each stretch held for 15 seconds, training continually during Radiation Therapy and up to one year after completion of Radiation Therapy.

Sponsors & Collaborators

• Linkoeping University

  collaborator OTHER_GOV

• Ryhov County Hospital

  collaborator OTHER

• University Hospital, Linkoeping

  lead OTHER

Principal Investigators

• Sussanne Börjeson, Med dr · Department of Medicine and Care, Division of Nursing Sciences, Faculty of Health Sciences, Linköping University, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2016-04-30

Completion

2016-06-30

Countries

• Sweden

Study Locations