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

Tracking Information

First Received Date ^ICMJE

June 1, 2006

Last Updated Date

March 19, 2007

Start Date ^ICMJE

June 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing

Original Primary Outcome Measures ^ICMJE

Objective swallowing using vidiofluoroscopy and endoscopic evaluation of swallowing

Change History

Complete list of historical versions of study NCT00332865 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain and swallowing endpoint of EORTC H&B35
Weight
Duration of tube feeding

Original Secondary Outcome Measures ^ICMJE

Pain and swallowing endpoint of EORTC H&B35
Weigth
Duration of tube feeding

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

Official Title ^ICMJE

Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Behavioral: Swallowing Exercises

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Estimated Completion Date

June 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kenneth Jensen, MD

+45 89492651

kjens@as.aaa.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00332865

Other Study ID Numbers ^ICMJE

20060059

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kenneth Jensen, MD

Aarhus University Hospital

Information Provided By

University of Aarhus

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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