Trial Outcomes & Findings for Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients (NCT NCT00629265)
NCT ID: NCT00629265
Last Updated: 2014-10-31
Results Overview
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.
COMPLETED
NA
170 participants
Before and after treatment
2014-10-31
Participant Flow
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.
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.
Participant milestones
| Measure |
Active NMES + Swallowing Exercise
Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
|
Sham NMES + Swallowing Exercise
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 Study
STARTED
|
116
|
54
|
|
Overall Study
COMPLETED
|
84
|
34
|
|
Overall Study
NOT COMPLETED
|
32
|
20
|
Reasons for withdrawal
| Measure |
Active NMES + Swallowing Exercise
Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
|
Sham NMES + Swallowing Exercise
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 Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
11
|
8
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
HNC Recurrence
|
4
|
0
|
|
Overall Study
Other CA Requiring Treatment
|
1
|
3
|
|
Overall Study
Needed Esophageal Dilation
|
4
|
1
|
|
Overall Study
Unrelated Medical Complications
|
3
|
1
|
|
Overall Study
Unknown Reason
|
2
|
2
|
Baseline Characteristics
Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Baseline characteristics by cohort
| Measure |
Active NMES Group
n=116 Participants
NMES therapy combined with exercise therapy
|
Sham NMES Group
n=54 Participants
Sham NMES combined with exercise therapy
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=5 Participants
|
54 participants
n=7 Participants
|
170 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before and after treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Active NMES + Swallowing Exercise
n=90 Participants
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 + Swallowing Exercise
n=35 Participants
Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
|
|---|---|---|
|
Change in Penetration-Aspiration Scale (PAS) Score
|
0.01 Change in points on PAS
Standard Deviation 1.04
|
-0.57 Change in points on PAS
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: Before and after treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Active NMES + Swallowing Exercise
n=91 Participants
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 + Swallowing Exercise
n=35 Participants
Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
|
|---|---|---|
|
Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)
Change in Total PSS score
|
6.25 Change in PSS and HNCI score
Standard Deviation 14.45
|
4.52 Change in PSS and HNCI score
Standard Deviation 16.06
|
|
Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)
Change in HNCI Eating Domain
|
6.31 Change in PSS and HNCI score
Standard Deviation 17.92
|
6.74 Change in PSS and HNCI score
Standard Deviation 15.59
|
Adverse Events
Active NMES + Swallowing Exercise
Sham (Inactive) NMES + Swallowing Exercise
Serious adverse events
| Measure |
Active NMES + Swallowing Exercise
n=116 participants at risk
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 + Swallowing Exercise
n=54 participants at risk
Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
|
|---|---|---|
|
General disorders
Death
|
1.7%
2/116 • Number of events 2 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Recurrence in Head & Neck
|
2.6%
3/116 • Number of events 3 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New Cancer / METs (other than Head & Neck)
|
0.00%
0/116 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.7%
2/116 • Number of events 2 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Excision of Necrotic Mass
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/116 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Airway obstruction
|
0.00%
0/116 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Immune system disorders
Acute allergic reaction to cat
|
0.00%
0/116 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Surgical and medical procedures
Lung biopsy for suspicious mass
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Gastrointestinal disorders
PEG Complications
|
1.7%
2/116 • Number of events 2 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Blood and lymphatic system disorders
Blood pressure complications
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
General disorders
Dehydration requiring hospitilization
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of COPD
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Progressive shortness of breath
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
Other adverse events
| Measure |
Active NMES + Swallowing Exercise
n=116 participants at risk
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 + Swallowing Exercise
n=54 participants at risk
Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Tongue tingling / edema
|
1.7%
2/116 • Number of events 2 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Gastrointestinal disorders
Severe Heartburn
|
0.00%
0/116 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain / discomfort in neck / throat
|
3.4%
4/116 • Number of events 5 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
2.6%
3/116 • Number of events 3 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
General disorders
Blood in sputum
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
General disorders
Common Cold / Fever / Not Feeling Well
|
1.7%
2/116 • Number of events 2 • 3 years, 4 months
|
5.6%
3/54 • Number of events 3 • 3 years, 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Gastrointestinal disorders
Constipation
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Surgical and medical procedures
Bronchoscopy for RLL infiltrate
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
General disorders
Patient over-medicated
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
General disorders
Unable to tolerate electrode placement it c/o dizziness
|
0.00%
0/116 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/116 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing d/t glottic stenosis
|
0.00%
0/116 • 3 years, 4 months
|
1.9%
1/54 • Number of events 1 • 3 years, 4 months
|
|
General disorders
Pain related to oral biopsy
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Surgical and medical procedures
Lung biopsy for suspicious mass
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
|
Gastrointestinal disorders
Worstening of swallow - more difficult
|
0.86%
1/116 • Number of events 1 • 3 years, 4 months
|
0.00%
0/54 • 3 years, 4 months
|
Additional Information
Dr. Susan Langmore, PhD, Director of Speech Language Pathology
Boston Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place