Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Jensen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT00332865
First received: June 1, 2006
Last updated: June 18, 2013
Last verified: June 2013
  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:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing [ Time Frame: 2 mths ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight [ Time Frame: 2 mths ] [ Designated as safety issue: No ]
  • Duration of tube feeding [ Time Frame: 2 mths ] [ Designated as safety issue: No ]
  • Swallowing scale of EORTC HN 35 [ Time Frame: 2 mths ] [ Designated as safety issue: No ]

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

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

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

No publications provided

Responsible Party: Kenneth Jensen, MD ph.d., University of Aarhus
ClinicalTrials.gov Identifier: NCT00332865     History of Changes
Other Study ID Numbers: 20060059
Study First Received: June 1, 2006
Last Updated: June 18, 2013
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 April 23, 2014