Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

University of Aarhus

Status and phase: Completed; Phase 2; Phase 1

Conditions: Head and Neck Cancer

Treatments: Behavioral: Swallowing Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT00332865

20060059

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)