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OpenTrials
Completed

NCT Number: NCT00332865

Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

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.

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Key information

Conditions

Head and Neck Cancer Behavior Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Motor Activity Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Swallowing Exercises

Behavioral

Daily exercises

Primary outcomes

  1. Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing

    Time frame: 2 mths

Secondary outcomes

  1. Weight

    Time frame: 2 mths

  2. Duration of tube feeding

    Time frame: 2 mths

  3. Swallowing scale of EORTC HN 35

    Time frame: 2 mths

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Jun 2, 2006
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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