Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy

Not Applicable

Completed

• Conditions: Nasopharyngeal Cancer; Dysphagia
• Interventions: Other: effortful swallowing exercise; Other: Mendelsohn swallowing exercise

• Registration Number: NCT01937793
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
effortful swallowing exercise	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.
Mendelsohn swallowing exercise	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in videofluoroscopic swallowing study (VFSS)	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

Name	Time	Method
Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL)	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei city, Taiwan