Back to resultsSwallow Exercise as Prophylaxis of Dysphagia After Radiotherapy
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Swallowing Exercises
Sponsored by
About this trial
This is an interventional prevention trial for Head and Neck Cancer focused on measuring Head and neck cancer, Radiotherapy, Dysphagia, Exercise, Deglutition, Randomized controlled trial, Quality of life, Tube feeding
Eligibility Criteria
Inclusion Criteria: Head and neck cancer Planned curative radiotherapy Planned irradiation of level II+III lymph nodes >46 Gy >=18 y Speaks and reads Danish No previous Surgery to the head and neck area except biopsies Exclusion Criteria: -
Sites / Locations
- Aarhus University Hospital
Outcomes
Primary Outcome Measures
Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing
Secondary Outcome Measures
Weight
Duration of tube feeding
Swallowing scale of EORTC HN 35
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00332865
Brief Title
Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy
Official Title
Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Dysphagia is a common side effect after radiotherapy for haed and neck cancer patients. It may be worsened by immobility of the throat during tube feeding. Hypothesis: Exercises may prevent or reduce late dysphagia. Method: Phase I study to identify the tolerated intensity of exercises and establish the method of measuring training intensity and dysphagia measurement. Endpoint: Objective dysphagia using VF and FEESST. The HN swallowing and HN pain endpoint of EORTC H&N35 questionnaire. Weight loss, duration of tube feeding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and neck cancer, Radiotherapy, Dysphagia, Exercise, Deglutition, Randomized controlled trial, Quality of life, Tube feeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Swallowing Exercises
Intervention Description
Daily exercises
Primary Outcome Measure Information:
Title
Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing
Time Frame
2 mths
Secondary Outcome Measure Information:
Title
Weight
Time Frame
2 mths
Title
Duration of tube feeding
Time Frame
2 mths
Title
Swallowing scale of EORTC HN 35
Time Frame
2 mths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Head and neck cancer
Planned curative radiotherapy
Planned irradiation of level II+III lymph nodes >46 Gy
>=18 y
Speaks and reads Danish
No previous Surgery to the head and neck area except biopsies
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Jensen, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy
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