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Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy

Primary Purpose

Nasopharyngeal Cancer, Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
effortful swallowing exercise
Mendelsohn swallowing exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Cancer focused on measuring radiation, speech-language pathology

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

effortful swallowing exercise

Mendelsohn swallowing exercise

Arm Description

Subjects in the arm are asked to do the effortful swallowing exercise at home for 8 weeks. The training frequency is to exercise 3-4 days/week, 3 times/day, 10 repetitions per time. Besides the at home exercise, each subject is scheduled to meet the investigator at the hospital at weekly basis to discuss and review his/her exercise practice.

Subjects in the arm are asked to do the Mendelsohn swallowing exercise at home for 8 weeks. The training frequency is to exercise 3-4 days/week, 3 times/day, 10 repetitions per time. Besides the at home exercise, each subject is scheduled to meet the investigator at the hospital at weekly basis to discuss and review his/her exercise practice.

Outcomes

Primary Outcome Measures

Change from Baseline in videofluoroscopic swallowing study (VFSS)
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 Outcome Measures

Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL)
The Chinese version of SWAL-QOL questionnaire (CSWAL-QOL) contains 10 scales related to swallowing and quality of life, including burden, eating desire, food duration, food selection, communication, fear, mental health, social functioning, sleep, and fatigue. All scales are linearly transformed into a 0-to-100 metric, with 0 indicating most dysfunction and 100 indicating no dysfunction.

Full Information

First Posted
January 30, 2013
Last Updated
April 16, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01937793
Brief Title
Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy
Official Title
Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Cancer, Dysphagia
Keywords
radiation, speech-language pathology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
effortful swallowing exercise
Arm Type
Active Comparator
Arm Description
Subjects in the arm are asked to do the effortful swallowing exercise at home for 8 weeks. The training frequency is to exercise 3-4 days/week, 3 times/day, 10 repetitions per time. Besides the at home exercise, each subject is scheduled to meet the investigator at the hospital at weekly basis to discuss and review his/her exercise practice.
Arm Title
Mendelsohn swallowing exercise
Arm Type
Active Comparator
Arm Description
Subjects in the arm are asked to do the Mendelsohn swallowing exercise at home for 8 weeks. The training frequency is to exercise 3-4 days/week, 3 times/day, 10 repetitions per time. Besides the at home exercise, each subject is scheduled to meet the investigator at the hospital at weekly basis to discuss and review his/her exercise practice.
Intervention Type
Other
Intervention Name(s)
effortful swallowing exercise
Intervention Description
voluntarily increases the posterior tongue base pushing effort while swallowing
Intervention Type
Other
Intervention Name(s)
Mendelsohn swallowing exercise
Intervention Description
voluntarily increase the extent and duration of laryngeal elevation while swallowing
Primary Outcome Measure Information:
Title
Change from Baseline in videofluoroscopic swallowing study (VFSS)
Description
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.
Time Frame
Change from Baseline in VFSS at 8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL)
Description
The Chinese version of SWAL-QOL questionnaire (CSWAL-QOL) contains 10 scales related to swallowing and quality of life, including burden, eating desire, food duration, food selection, communication, fear, mental health, social functioning, sleep, and fatigue. All scales are linearly transformed into a 0-to-100 metric, with 0 indicating most dysfunction and 100 indicating no dysfunction.
Time Frame
Change from Baseline in CSWAL-QOL at 8 weeks
Other Pre-specified Outcome Measures:
Title
Change from Baseline in the Mann Assessment of Swallowing Ability (MASA)
Description
The the Mann Assessment of Swallowing Ability (MASA) is designed to yield specific information about a patients's swallowing ability through examiner interpretation of responses. Two scores are obtained: a total score out of 200, and an ordinal risk rating for both aspiration and dysphagia (definite, probable, possible, unlikely).
Time Frame
Change from Baseline in MASA at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenq-Yuh Ko, M.D., Ph.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei city
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
11733879
Citation
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Links:
URL
http://www.asha.org/
Description
American Speech-Language-Hearing Association

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Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy

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