Jaw Training to Increase Jaw Mobility During Radiotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University Hospital, Linkoeping.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Linkoeping University
Ryhov County Hospital
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01354548
First received: May 2, 2011
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Trismus
Device: TheraBite® Jaw Motion Rehabilitation System™

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylactic Training for the Prevention of Trismus in Connection With Radiation Therapy - a Randomised Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TheraBite grupp 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.
No Intervention: Conventional treatment

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354548

Contacts
Contact: Vera E Loorents + 46 10 103 2827 vera.loorents@lio.se
Contact: Kristina M Hultman +46 10 103 2827 kristina.m.hultman@lio.se

Locations
Sweden
Department of Radiation Oncology, Ryhov ,Sweden Recruiting
Jonkoping, Sweden, 551 85
Contact: Maria Lidback, R.N.R.T    036 323442 ext 46    Maria.Lidback@lj.se   
Contact: Charlott Karlsson    036 321678 ext 46    Charlott.Karlsson@lj.se   
Sub-Investigator: Maria Lidback, R.N.R.T         
Department of Radiation Oncology, University Hospital, Linkoping Recruiting
Linkoping, Sweden, 581 85
Contact: Hakan S Rydberg    010 103 1462 ext 46    Hakan.Rydberg@lio.se   
Contact: Ingrid Tillgren    010 103 7513    Ingrid.Tillgren@lio.se   
Principal Investigator: Vera E Loorents, R.N.R.T         
Sub-Investigator: Kristina M Hultman, R.N.R.T         
Sponsors and Collaborators
University Hospital, Linkoeping
Linkoeping University
Ryhov County Hospital
Investigators
Principal Investigator: Sussanne Börjeson, Med dr Department of Medicine and Care, Division of Nursing Sciences, Faculty of Health Sciences, Linköping University, Sweden
  More Information

Additional Information:
No publications provided

Responsible Party: Vera Loorents, Linkoeping University Hospital, Department of Radiation Oncology
ClinicalTrials.gov Identifier: NCT01354548     History of Changes
Other Study ID Numbers: FORSS-88571, The Swedish Cancer Society
Study First Received: May 2, 2011
Last Updated: May 16, 2011
Health Authority: Sweden: Regional Ethical Review Board
Sweden: The National Board of Health and Welfare
Sweden: Institutional Review Board

Keywords provided by University Hospital, Linkoeping:
Trismus
Cancer
Radiotherapy
Quality of life

Additional relevant MeSH terms:
Trismus
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014