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Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy


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:

-

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing

Outcome Time Frame:

2 mths

Safety Issue:

No

Principal Investigator

Kenneth Jensen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aarhus University Hospital

Authority:

Denmark: Danish Medicines Agency

Study ID:

20060059

NCT ID:

NCT00332865

Start Date:

June 2006

Completion Date:

June 2013

Related Keywords:

  • Head and Neck Cancer
  • Head and neck cancer
  • Radiotherapy
  • Dysphagia
  • Exercise
  • Deglutition
  • Randomized controlled trial
  • Quality of life
  • Tube feeding
  • Deglutition Disorders
  • Head and Neck Neoplasms

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