Prevention of Trismus During Radiotherapy and Quality of Life in Head and Neck Cancer Patients
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
3 other identifiers
interventional
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 2, 2011
CompletedFirst Posted
Study publicly available on registry
May 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedApril 14, 2016
April 1, 2016
6.2 years
May 2, 2011
April 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Jaw mobility measurement during Radiotherapy
Proportion of participants free from trismus at the end of Radiotherapy.
Up to 7 weeks
Secondary Outcomes (1)
Change in Jaw Mobility measurement at 6 and 12 months after completed Radiotherapy
6 and 12 months
Study Arms (2)
TheraBite grupp
EXPERIMENTALConventional treatment
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- An operation in the target area that has already affected jaw mobility.
- Jaw measurement under 35mm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Linkoepinglead
- Linkoeping Universitycollaborator
- Ryhov County Hospitalcollaborator
Study Sites (2)
Department of Radiation Oncology, Ryhov ,Sweden
Jönköping, 551 85, Sweden
Department of Radiation Oncology, University Hospital, Linkoping
Linköping, 581 85, Sweden
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sussanne Börjeson, Med dr
Department of Medicine and Care, Division of Nursing Sciences, Faculty of Health Sciences, Linköping University, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Project leader
Study Record Dates
First Submitted
May 2, 2011
First Posted
May 17, 2011
Study Start
February 1, 2010
Primary Completion
April 1, 2016
Study Completion
June 1, 2016
Last Updated
April 14, 2016
Record last verified: 2016-04