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Clinical Trials/NCT01937793
NCT01937793CompletedNot Applicable

Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy

National Taiwan University Hospital2 sites in 1 country16 target enrollmentStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
2
Primary Endpoint
Change from Baseline in videofluoroscopic swallowing study (VFSS)

Study Overview

Brief Summary

This study is designed to investigate the treatment efficacy of 8 weeks swallowing exercise programs for patients with NPC after radiation therapy. This study also compares two different swallowing exercise: effortful swallow and Mendelsohn's maneuver, to see which one can bring more benefits to patients after a certain period of exercise training. Three assessment tools are selected to evaluate the study result: Mann Assessment of Swallowing Ability (MASA), videofluoroscopic swallowing study (VFSS), and Chinese version Swallowing Quality-of-Life Questionnaire (CSWAL-QOL). The hypothesis of this study is that the effortful swallowing exercise would have better treatment efficacy.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients diagnosed with NPC
  • completed radiation therapy at least 1 year
  • mild to moderate swallowing disorder defined by videofluorography
  • able to comply with protocal mandate, willing to perform the exercise programs, and ability to attend the weekly sessions

Exclusion Criteria

  • feeding tube insitu
  • received pharyngeal surgery
  • tracheostomy tube insitu
  • patients who could not put effort to push posterior tongue base backward and who could not elevate their pharyngeal during swallowing
  • severe swallowing disorder or aspirate defined by videofluorography
  • other malignances, neurovascular disease, demyelinating disease
  • cancer relapse or metastases

Outcomes

Primary Outcomes

Change from Baseline in videofluoroscopic swallowing study (VFSS)

Time Frame: Change from Baseline in VFSS at 8 weeks

Videofluoroscopic swallowing study (VFSS) measures the bolus transit time including: 1.oral transit time; 2. pharyngeal transit time; and 3. pharyngeal delay time. It also reveals the occurrence of swallowing aspiration or not.

Secondary Outcomes

  • Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL)(Change from Baseline in CSWAL-QOL at 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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