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Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients

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ClinicalTrials.gov Identifier: NCT00629265
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Collaborators:
Northwestern University
Boston University
University of Wisconsin, Madison
New York University
VA Boston Healthcare System
Lahey Clinic
Lenox Hill Hospital
Beth Israel Medical Center
Greater Baltimore Medical Center
Henry Ford Hospital
University of California, San Diego
University of Washington
Mayo Clinic
Icahn School of Medicine at Mount Sinai
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Susan Langmore, Boston Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dysphagia
Intervention Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)
Enrollment 170
Recruitment Details 170 subjects were recruited/randomized into the study from 16 medical centers in the United States between January 2009 and December 2011. The majority of subjects were recruited during follow up visits in outpatient Otolaryngology & Radiation Oncology clinics.
Pre-assignment Details All potentially eligible patients were screened with a 19 question eligibility form. 488 patients were screened, of which 318 were not eligible or declined to participate. 170 patients were then randomized to either the Active NMES + Swallowing Exercise group or the Sham (inactive) NMES + Swallowing Exercise group.
Arm/Group Title Active NMES + Swallowing Exercise Sham NMES + Swallowing Exercise
Hide Arm/Group Description Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks. Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
Period Title: Overall Study
Started 116 54
Completed 84 34
Not Completed 32 20
Reason Not Completed
Lost to Follow-up             4             5
Withdrawal by Subject             11             8
Death             1             0
Adverse Event             2             0
HNC Recurrence             4             0
Other CA Requiring Treatment             1             3
Needed Esophageal Dilation             4             1
Unrelated Medical Complications             3             1
Unknown Reason             2             2
Arm/Group Title Active NMES Group Sham NMES Group Total
Hide Arm/Group Description NMES therapy combined with exercise therapy Sham NMES combined with exercise therapy Total of all reporting groups
Overall Number of Baseline Participants 116 54 170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 116 participants 54 participants 170 participants
62.1  (9.2) 61.5  (10.6) 61.9  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 54 participants 170 participants
Female
16
  13.8%
9
  16.7%
25
  14.7%
Male
100
  86.2%
45
  83.3%
145
  85.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 116 participants 54 participants 170 participants
116 54 170
1.Primary Outcome
Title Change in Penetration-Aspiration Scale (PAS) Score
Hide Description

The PAS scale is a validated 8-point ordinal scale (Rosenbek et. al 1996) in which a score of 1 is best (material does not enter the airway) and a score of 8 is worst (material enters the airway, passes below the vocal folds, and no effort is made to eject it).

Difference in mean PAS scores after 12 weeks of therapy was analyzed between the two groups of interest: Active NMES + Swallowing Exercise versus Sham (inactive) NMES + Swallowing Exercise. PAS scores were obtained from fluoroscopy (modified barium swallow) studies adminstered at three time points - enrollment, midway through treatment (6 weeks), and at end of treatment (12 weeks). All fluoroscopy studies were sent to, and analyzed by, a blinded external central laboratory.

Time Frame Before and after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Note: the number of participants analyzed (125) does not match the total number enrolled (170) because 45 people did not have adequate follow up data required for this primary analysis.
Arm/Group Title Active NMES + Swallowing Exercise Sham (Inactive) NMES + Swallowing Exercise
Hide Arm/Group Description:
Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
Overall Number of Participants Analyzed 90 35
Mean (Standard Deviation)
Unit of Measure: Change in points on PAS
0.01  (1.04) -0.57  (1.62)
2.Secondary Outcome
Title Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)
Hide Description

Perceive improved in quality of life and eating ability as measured by 2 validated scales: the Performance Status Scale for Head and Neck Cancer Patients (PSS) and The Head and Neck Cancer Inventory (HNCI).

The PSS (List, et. al., 1990) is a clinician adminsitered scale that has three domains (normalcy of diet, eating in public, and understandability of speech). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best.

The HNCI (Funk, et. al., 2003) is patient administered questionnaire that has four domains (social disruption, aesthetics, speech, eating). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best.

Time Frame Before and after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Note: the number of participants analyzed (126) does not match the total number enrolled (170) because 44 people did not have adequate follow up data required for this secondary analysis.
Arm/Group Title Active NMES + Swallowing Exercise Sham (Inactive) NMES + Swallowing Exercise
Hide Arm/Group Description:
Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
Overall Number of Participants Analyzed 91 35
Mean (Standard Deviation)
Unit of Measure: Change in PSS and HNCI score
Change in Total PSS score 6.25  (14.45) 4.52  (16.06)
Change in HNCI Eating Domain 6.31  (17.92) 6.74  (15.59)
Time Frame 3 years, 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active NMES + Swallowing Exercise Sham (Inactive) NMES + Swallowing Exercise
Hide Arm/Group Description Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks. Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
All-Cause Mortality
Active NMES + Swallowing Exercise Sham (Inactive) NMES + Swallowing Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Active NMES + Swallowing Exercise Sham (Inactive) NMES + Swallowing Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/116 (12.07%)      5/54 (9.26%)    
Blood and lymphatic system disorders     
Blood pressure complications   1/116 (0.86%)  1 0/54 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain   0/116 (0.00%)  0 1/54 (1.85%)  1
PEG Complications  [1]  2/116 (1.72%)  2 0/54 (0.00%)  0
General disorders     
Death   2/116 (1.72%)  2 0/54 (0.00%)  0
Dehydration requiring hospitilization   1/116 (0.86%)  1 0/54 (0.00%)  0
Immune system disorders     
Acute allergic reaction to cat   0/116 (0.00%)  0 1/54 (1.85%)  1
Musculoskeletal and connective tissue disorders     
Excision of Necrotic Mass   1/116 (0.86%)  1 0/54 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer Recurrence in Head & Neck  [2]  3/116 (2.59%)  3 0/54 (0.00%)  0
New Cancer / METs (other than Head & Neck)   0/116 (0.00%)  0 1/54 (1.85%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia   2/116 (1.72%)  2 1/54 (1.85%)  1
Airway obstruction   0/116 (0.00%)  0 1/54 (1.85%)  1
Exacerbation of COPD   1/116 (0.86%)  1 0/54 (0.00%)  0
Progressive shortness of breath  [3]  1/116 (0.86%)  1 0/54 (0.00%)  0
Surgical and medical procedures     
Lung biopsy for suspicious mass   1/116 (0.86%)  1 0/54 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
1 patient had an infection at PEG site and another had a blocked PEG
[2]
Two were base of tongue recurrances and one was a begnign vocal polyp
[3]
Laryngeal edema had been getting worse since end of RT and progressed to critical stage while in the study.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active NMES + Swallowing Exercise Sham (Inactive) NMES + Swallowing Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/116 (10.34%)      7/54 (12.96%)    
Gastrointestinal disorders     
Severe Heartburn   0/116 (0.00%)  0 1/54 (1.85%)  1
Diarrhea   1/116 (0.86%)  1 1/54 (1.85%)  1
Constipation   1/116 (0.86%)  1 0/54 (0.00%)  0
Worstening of swallow - more difficult   1/116 (0.86%)  1 0/54 (0.00%)  0
General disorders     
Blood in sputum   1/116 (0.86%)  1 0/54 (0.00%)  0
Common Cold / Fever / Not Feeling Well   2/116 (1.72%)  2 3/54 (5.56%)  3
Patient over-medicated   1/116 (0.86%)  1 0/54 (0.00%)  0
Unable to tolerate electrode placement it c/o dizziness   0/116 (0.00%)  0 1/54 (1.85%)  1
Pain related to oral biopsy   1/116 (0.86%)  1 0/54 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Tongue tingling / edema   2/116 (1.72%)  2 0/54 (0.00%)  0
Pain / discomfort in neck / throat   4/116 (3.45%)  5 1/54 (1.85%)  1
Respiratory, thoracic and mediastinal disorders     
Coughing   3/116 (2.59%)  3 0/54 (0.00%)  0
Upper respiratory infection   0/116 (0.00%)  0 1/54 (1.85%)  1
Difficulty breathing d/t glottic stenosis   0/116 (0.00%)  0 1/54 (1.85%)  1
Surgical and medical procedures     
Bronchoscopy for RLL infiltrate   1/116 (0.86%)  1 0/54 (0.00%)  0
Lung biopsy for suspicious mass   1/116 (0.86%)  1 0/54 (0.00%)  0
Indicates events were collected by systematic assessment
Because of funding limitations research assistants could not be hired at most sites, and so 170 (instead of 240) subjects were enrolled. However, the results suggest additional patients would not have changed the outcome.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Susan Langmore, PhD, Director of Speech Language Pathology
Organization: Boston Medical Center
Phone: 617-414-1753
EMail: langmore@bu.edu
Layout table for additonal information
Responsible Party: Susan Langmore, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00629265    
Other Study ID Numbers: H-26283
5R01CA120950 ( U.S. NIH Grant/Contract )
First Submitted: January 30, 2008
First Posted: March 5, 2008
Results First Submitted: August 28, 2013
Results First Posted: October 31, 2014
Last Update Posted: October 31, 2014