Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

NCT ID: NCT00332865

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2013-06-30

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Swallowing Exercises

Daily exercises

Intervention Type: BEHAVIORAL

Eligibility 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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Jensen

MD ph.d.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, Aarhus, Denmark

Countries

Denmark

Other Identifiers

20060059

Identifier Type: -

Identifier Source: org_study_id