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Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332865
First Posted: June 2, 2006
Last Update Posted: June 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth Jensen, University of Aarhus
  Purpose
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.

Condition Intervention Phase
Head and Neck Cancer Behavioral: Swallowing Exercises Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

Resource links provided by NLM:


Further study details as provided by Kenneth Jensen, University of Aarhus:

Primary Outcome Measures:
  • Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing [ Time Frame: 2 mths ]

Secondary Outcome Measures:
  • Weight [ Time Frame: 2 mths ]
  • Duration of tube feeding [ Time Frame: 2 mths ]
  • Swallowing scale of EORTC HN 35 [ Time Frame: 2 mths ]

Estimated Enrollment: 60
Study Start Date: June 2006
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Swallowing Exercises
    Daily exercises
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332865


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Kenneth Jensen, MD Aarhus University Hospital
  More Information

Responsible Party: Kenneth Jensen, MD ph.d., University of Aarhus
ClinicalTrials.gov Identifier: NCT00332865     History of Changes
Other Study ID Numbers: 20060059
First Submitted: June 1, 2006
First Posted: June 2, 2006
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Kenneth Jensen, University of Aarhus:
Head and neck cancer
Radiotherapy
Dysphagia
Exercise
Deglutition
Randomized controlled trial
Quality of life
Tube feeding

Additional relevant MeSH terms:
Head and Neck Neoplasms
Deglutition Disorders
Neoplasms by Site
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases