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Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00332865
Enrollment
60
Registered
2006-06-02
Start date
2006-06-30
Completion date
2013-06-30
Last updated
2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer, Radiotherapy, Dysphagia, Exercise, Deglutition, Randomized controlled trial, Quality of life, Tube feeding

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.

Interventions

Daily exercises

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frame
Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing2 mths

Secondary

MeasureTime frame
Weight2 mths
Duration of tube feeding2 mths
Swallowing scale of EORTC HN 352 mths

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026