NCT01937793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

January 30, 2013

Last Update Submit

April 16, 2014

Conditions

Nasopharyngeal CancerDysphagia

Keywords

radiationspeech-language pathology

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline in VFSS at 8 weeks

Secondary Outcomes (1)

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

    Change from Baseline in CSWAL-QOL at 8 weeks

Other Outcomes (1)

  • Change from Baseline in the Mann Assessment of Swallowing Ability (MASA)

    Change from Baseline in MASA at 8 weeks

Study Arms (2)

effortful swallowing exercise

ACTIVE COMPARATOR

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

Mendelsohn swallowing exercise

ACTIVE COMPARATOR

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

Interventions

effortful swallowing exerciseOTHER

voluntarily increases the posterior tongue base pushing effort while swallowing

effortful swallowing exercise
Mendelsohn swallowing exerciseOTHER

voluntarily increase the extent and duration of laryngeal elevation while swallowing

Mendelsohn swallowing exercise

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Related Publications (14)

  • Hind JA, Nicosia MA, Roecker EB, Carnes ML, Robbins J. Comparison of effortful and noneffortful swallows in healthy middle-aged and older adults. Arch Phys Med Rehabil. 2001 Dec;82(12):1661-5. doi: 10.1053/apmr.2001.28006.

    PMID: 11733879BACKGROUND

  • Huang HY, Wilkie DJ, Schubert MM, Ting LL. Symptom profile of nasopharyngeal cancer patients during radiation therapy. Cancer Pract. 2000 Nov-Dec;8(6):274-81. doi: 10.1046/j.1523-5394.2000.86007.x.

    PMID: 11898144BACKGROUND

  • Hughes PJ, Scott PM, Kew J, Cheung DM, Leung SF, Ahuja AT, van Hasselt CA. Dysphagia in treated nasopharyngeal cancer. Head Neck. 2000 Jul;22(4):393-7. doi: 10.1002/1097-0347(200007)22:43.0.co;2-2.

    PMID: 10862024BACKGROUND

  • Kotz T, Federman AD, Kao J, Milman L, Packer S, Lopez-Prieto C, Forsythe K, Genden EM. Prophylactic swallowing exercises in patients with head and neck cancer undergoing chemoradiation: a randomized trial. Arch Otolaryngol Head Neck Surg. 2012 Apr;138(4):376-82. doi: 10.1001/archoto.2012.187.

    PMID: 22508621BACKGROUND

  • Ku PK, Yuen EH, Cheung DM, Chan BY, Ahuja A, Leung SF, Tong MC, van Hasselt A. Early swallowing problems in a cohort of patients with nasopharyngeal carcinoma: Symptomatology and videofluoroscopic findings. Laryngoscope. 2007 Jan;117(1):142-6. doi: 10.1097/01.mlg.0000248738.55387.44.

    PMID: 17202944BACKGROUND

  • Kulbersh BD, Rosenthal EL, McGrew BM, Duncan RD, McColloch NL, Carroll WR, Magnuson JS. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006 Jun;116(6):883-6. doi: 10.1097/01.mlg.0000217278.96901.fc.

    PMID: 16735913BACKGROUND

  • Lam PM, Lai CK. The validation of the Chinese version of the Swallow Quality-of-Life Questionnaire (SWAL-QOL) using exploratory and confirmatory factor analysis. Dysphagia. 2011 Jun;26(2):117-24. doi: 10.1007/s00455-010-9272-6. Epub 2010 Mar 4.

    PMID: 20204414BACKGROUND

  • Lazarus C, Logemann JA, Song CW, Rademaker AW, Kahrilas PJ. Effects of voluntary maneuvers on tongue base function for swallowing. Folia Phoniatr Logop. 2002 Jul-Aug;54(4):171-6. doi: 10.1159/000063192.

    PMID: 12169803BACKGROUND

  • Logemann JA. Role of the modified barium swallow in management of patients with dysphagia. Otolaryngol Head Neck Surg. 1997 Mar;116(3):335-8. doi: 10.1016/S0194-59989770269-9.

    PMID: 9121786BACKGROUND

  • Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21. doi: 10.1053/gast.2002.32999.

    PMID: 11984518BACKGROUND

  • Tang Y, Shen Q, Wang Y, Lu K, Wang Y, Peng Y. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus. Strahlenther Onkol. 2011 Jan;187(1):39-44. doi: 10.1007/s00066-010-2151-0. Epub 2010 Dec 10.

    PMID: 21136031BACKGROUND

  • van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Rasch CR, Hilgers FJ. A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects. Dysphagia. 2011 Jun;26(2):155-70. doi: 10.1007/s00455-010-9288-y. Epub 2010 Jul 11.

    PMID: 20623305BACKGROUND

  • Wang TG, Chang YC, Chen WS, Lin PH, Hsiao TY. Reduction in hyoid bone forward movement in irradiated nasopharyngeal carcinoma patients with dysphagia. Arch Phys Med Rehabil. 2010 Jun;91(6):926-31. doi: 10.1016/j.apmr.2010.02.011.

    PMID: 20510985BACKGROUND

  • Wu CH, Hsiao TY, Ko JY, Hsu MM. Dysphagia after radiotherapy: endoscopic examination of swallowing in patients with nasopharyngeal carcinoma. Ann Otol Rhinol Laryngol. 2000 Mar;109(3):320-5. doi: 10.1177/000348940010900315.

    PMID: 10737318BACKGROUND

Related Links

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsDeglutition Disorders

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Jenq-Yuh Ko, M.D., Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2013

First Posted

September 10, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

TW(1)