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Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00332865
First received: June 1, 2006
Last updated: March 19, 2007
Last verified: March 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing

Secondary Outcome Measures:
  • Pain and swallowing endpoint of EORTC H&B35
  • Weight
  • Duration of tube feeding

Estimated Enrollment: 60
Study Start Date: June 2006
Estimated Study Completion Date: June 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332865

Contacts
Contact: Kenneth Jensen, MD +45 89492651 kjens@as.aaa.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Kenneth Jensen, MD     +45 89492651     kjens@as.aaa.dk    
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Kenneth Jensen, MD Aarhus University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00332865     History of Changes
Other Study ID Numbers: 20060059
Study First Received: June 1, 2006
Last Updated: March 19, 2007
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on May 21, 2013