Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

Phase 1

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00332865
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing	2 mths

Secondary Outcome Measures

Name	Time	Method
Weight	2 mths
Duration of tube feeding	2 mths
Swallowing scale of EORTC HN 35	2 mths

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark