Jaw Training to Increase Jaw Mobility During Radiotherapy

• Change in Jaw mobility measurement during Radiotherapy [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
  Proportion of participants free from trismus at the end of Radiotherapy.
  
  

• Change in Jaw Mobility measurement at 6 and 12 months after completed Radiotherapy [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  Proportion of participants free from trismus 6 and 12 months after completed Radiotherapy.
  
  

Summary of the study programme

Background

During Radiation therapy to the mouth, throat or trachea can fibrosis often occur in the chewing muscles round the jaw causing a development of trismus (a limited jaw mobility). Trismus can cause pain, difficulty in eating, swallowing, speech and difficulty with general mouth hygiene. Despite the fact that this condition has been documented in older literature, there is limited research in the incidence of trismus. There is need of randomised studies to investigate the prevention of trismus both under and during Radiation Therapy.

Aims

The specific aims of this study are to investigate the effectiveness of Prophylactic training with a muscle warm-up programme and a mechanical device (TheraBite) to prevent trismus during Radiation Therapy and one year after completed therapy. The study also aims to investigate the incidence of radiotherapy-induced trismus in patients who receive radiotherapy to the masseter, temporalis, pterygoid muscles. Finally the study investigates whether trismus affects quality of life.

Methods

Patients

Sixty consecutive patients, from two different radiation clinics in Sweden, are randomised into the two different groups using a computer programme.

Treatment procedures

1. Intervention group: Daily training with a programme for TheraBite that trains passive movement, preceded by a warm-up programme. Mouth opening measurements are made once a week during treatment at the end of radiotherapy,three, six and 12 months after treatment.
2. Control group: Receiving traditional radiation therapy with nursing care, measuring the patients mouth opening once a week during treatment, at the end of radiation therapy,three, six, and 12 months after treatment. The same training programme as group one is offered to this group as soon as evidence of trismus develops.

This training is recorded by the patient in a log book. Weight, height, Mucositis analysis and quality of life are made before the commencement of radiation therapy, at the end of radiation therapy, three, six, and 12 months after treatment. The patient's weight is measured every week.

Results

The results of this study will give new and vital information that can give a basis to develop a clinical method of identifying and treating cancer patients who suffer from trismus. Thus giving new knowledge which can be used to formulate clinical practices.