Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

June 18, 2013 updated by: Kenneth Jensen, University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing
Time Frame: 2 mths
2 mths

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 2 mths
2 mths
Duration of tube feeding
Time Frame: 2 mths
2 mths
Swallowing scale of EORTC HN 35
Time Frame: 2 mths
2 mths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Kenneth Jensen, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (Estimate)

June 2, 2006

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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