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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01354548 |
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Date of registration:
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02/05/2011 |
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Primary sponsor: |
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Public title:
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Jaw Training to Increase Jaw Mobility During Radiotherapy
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Scientific title:
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Prophylactic Training for the Prevention of Trismus in Connection With Radiation Therapy - a Randomised Study |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01354548 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Vera E Loorents |
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Address:
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Telephone:
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+ 46 10 103 2827 |
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Email:
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vera.loorents@lio.se |
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Affiliation:
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Name:
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Sussanne Börjeson, Med dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Medicine and Care, Division of Nursing Sciences, Faculty of Health Sciences, Linköping University, Sweden |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Trismus
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Intervention(s)
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Device: TheraBite® Jaw Motion Rehabilitation System™
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Primary Outcome(s)
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Change in Jaw mobility measurement during Radiotherapy
[Time Frame: Up to 7 weeks]
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Secondary Outcome(s)
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Change in Jaw Mobility measurement at 6 and 12 months after completed Radiotherapy
[Time Frame: 6 and 12 months]
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Secondary ID(s)
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FORSS-88571
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The Swedish Cancer Society
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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