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Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy

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ClinicalTrials.gov Identifier: NCT01937793
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Cancer Dysphagia Other: effortful swallowing exercise Other: Mendelsohn swallowing exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy
Study Start Date : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: effortful swallowing exercise
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.
Other: effortful swallowing exercise
voluntarily increases the posterior tongue base pushing effort while swallowing

Active Comparator: Mendelsohn swallowing exercise
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.
Other: Mendelsohn swallowing exercise
voluntarily increase the extent and duration of laryngeal elevation while swallowing




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL) [ Time Frame: Change from Baseline in CSWAL-QOL at 8 weeks ]
    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.


Other Outcome Measures:
  1. Change from Baseline in the Mann Assessment of Swallowing Ability (MASA) [ Time Frame: Change from Baseline in MASA at 8 weeks ]
    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).



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937793


Locations
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Taiwan
National Taiwan University Hospital
Taipei city, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Jenq-Yuh Ko, M.D., Ph.D. National Taiwan University Hospital

Additional Information:
Publications:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01937793     History of Changes
Other Study ID Numbers: 201211062RIB
000766KJY ( Other Identifier: National Taiwan University Hospital )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014

Keywords provided by National Taiwan University Hospital:
radiation
speech-language pathology

Additional relevant MeSH terms:
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Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Carcinoma