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CompletedNCT00332865Updated Jun 19, 2013

Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

A Phase 1/2 interventional study of Swallowing Exercises in Head and Neck Cancer, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-19.

Sponsored by University of Aarhus · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Cancer

Keywords

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

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 60 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

-

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Interventions

  • BehavioralSwallowing Exercises

    Daily exercises

06

What researchers measure

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

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00332865
Lead sponsor
University of Aarhus
Responsible party
Kenneth Jensen (MD ph.d., University of Aarhus) — Principal investigator
First posted
Jun 2, 2006
Start date
Jun 2006
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Jun 19, 2013

Study contacts

Kenneth Jensen, MD
principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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