TrismusNCT01354548
Prevention of Trismus During Radiotherapy and Quality of Life in Head and Neck Cancer Patients
A study testing TheraBite® Jaw Motion Rehabilitation System™ in people with Trismus, run by University Hospital, Linkoeping at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trismus
- What is being tested?
- TheraBite® Jaw Motion Rehabilitation System™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSweden
- Study dates
- Feb 2010to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- An operation in the target area that has already affected jaw mobility.
- Jaw measurement under 35mm.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Department of Radiation Oncology, Ryhov ,Sweden
Jönköping, 551 85
Department of Radiation Oncology, University Hospital, Linkoping
Linköping, 581 85
About this study
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
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.
Read more
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.
Read the 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
- 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.
- 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.
- Conditions
- Trismus
- Being tested
- TheraBite® Jaw Motion Rehabilitation System™
- Keywords
- Trismus, Cancer, Radiotherapy, Quality of life
- Medical subject headings
- Trismus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraBite® Jaw Motion Rehabilitation System™Device
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.
| Study group | Role | What they receive |
|---|---|---|
| TheraBite grupp | Experimental | Not described Receives: Device: TheraBite® Jaw Motion Rehabilitation System™ |
| Conventional treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Jaw mobility measurement during Radiotherapy
Proportion of participants free from trismus at the end of Radiotherapy.
Measured: Up to 7 weeks
Secondary outcomes (1)
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startFeb 2010
- Primary completionApr 2016
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Ryhov County Hospital
- Responsible party
- Principal investigator, Vera Loorents, University Hospital, Linkoeping
- Investigators
- Sussanne Börjeson, Med dr, Principal investigator, Department of Medicine and Care, Division of Nursing Sciences, Faculty of Health Sciences, Linköping University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354548
- Sponsor's protocol ID
- FORSS-88571
- Other IDs
- The Swedish Cancer Society, FoU
- Status last verified
- Apr 2016
- First submitted
- 2 May 2011
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01354548
- Acronym / sponsor ID
- FORSS-88571
- Conditions
- Trismus
- Keywords
- Trismus, Cancer, Radiotherapy, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Linkoeping University, Ryhov County Hospital
- Study start
- Feb 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TheraBite grupp | Experimental | Device: TheraBite® Jaw Motion Rehabilitation System™ |
| Conventional treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- An operation in the target area that has already affected jaw mobility.
- Jaw measurement under 35mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | TheraBite grupp |
Primary outcome
Change in Jaw mobility measurement during Radiotherapy
Time frame: Up to 7 weeks
Proportion of participants free from trismus at the end of Radiotherapy.
1 secondary outcome
Change in Jaw Mobility measurement at 6 and 12 months after completed Radiotherapy
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Link to the Medical research council of Southeast SwedenLink provided by the sponsor.
- Link to the Swedish cancer SocietyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sussanne Börjeson, Med dr principal investigator
Department of Medicine and Care, Division of Nursing Sciences, Faculty of Health Sciences, Linköping University, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraBite® Jaw Motion Rehabilitation System™ in people with Trismus, run by University Hospital, Linkoeping at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Jaw mobility measurement during Radiotherapy (time frame: Up to 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.