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Completed

NCT Number: NCT01937793

Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy

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.

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Key information

Conditions

Nasopharyngeal Cancer Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan, 100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

effortful swallowing exercise

Other

voluntarily increases the posterior tongue base pushing effort while swallowing

Mendelsohn swallowing exercise

Other

voluntarily increase the extent and duration of laryngeal elevation while swallowing

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2013
Registry last updated
Apr 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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