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

Trismus Clinical Trial

Official title:

Prophylactic Training for the Prevention of Radiotherapy-induced Trismus - a Randomised Study. Health-related Quality of Life up to One Year After Radiotherapy in Patients With Head and Neck Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01354548
• Other study ID #: FORSS-88571
• Secondary ID: The Swedish Canc
• Status: Active, not recruiting
• Phase: N/A
• First received: May 2, 2011
• Last updated: April 13, 2016
• Start date: February 2010
• Est. completion date: June 2016

Study information

• Verified date: April 2016
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: The National Board of Health and WelfareSweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Be able to communicate and understand the Swedish language.

• Compliance with training programme and follow-up during the study time period.

• Planed radiotherapy dose of at least 15Gy to the jaw muscles.

• Tooth 11 and 41 intact.

Exclusion Criteria:

• An operation in the target area that has already affected jaw mobility.

• Jaw measurement under 35mm.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Trismus

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Radiation Oncology, Ryhov ,Sweden	Jonkoping
Sweden	Department of Radiation Oncology, University Hospital, Linkoping	Linkoping

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Linkoeping University, Ryhov County Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Jaw mobility measurement during Radiotherapy	Proportion of participants free from trismus at the end of Radiotherapy.	Up to 7 weeks	No
Secondary	Change in Jaw Mobility measurement at 6 and 12 months after completed Radiotherapy	Proportion of participants free from trismus 6 and 12 months after completed Radiotherapy.	6 and 12 months	No

External Links

•   Link to the Medical research council of Southeast Sweden
•   Link to the Swedish cancer Society