Dysphagia
Conditions
Keywords
Dysphagia, Neuromuscular Electrical Stimulation (NMES), Head & Neck Cancer, Radiation and ChemoTherapy
Brief summary
The purpose of the investigation is to learn whether intense swallowing exercise or intense swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had head/neck cancer and currently have dysphagia swallow better.
Detailed description
Head and neck cancer patients have a better chance of survival in the 21st century because of radiation therapy (RT), either alone or in combination with surgery and/or chemotherapy (CRT). Such therapy has a high rate of local / regional control, and may extend duration of life. Unfortunately the elimination of the cancer can leave devastating side effects, including the inability to eat and swallow normally. Organ preservation, often assumed to be the preferred treatment, has now been shown to magnify dysphagia. Incidence of dysphagia in this group of patients is extremely high, with symptoms continuing to deteriorate for several years after treatment. Conventional therapy for dysphagia yields only minor benefit. Persistence of dysphagia has a major impact on the quality of life of these cancer survivors. Recently, a new therapy approach has been introduced for dysphagia, called e-stim or Neuromuscular Electrical Stimulation (NMES). Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction. An aggressive marketing campaign has turned e-stim into a very popular and sought-after therapy for dysphagia. However, there are no efficacy studies demonstrating its true benefit. We have collected preliminary data with Head & Neck cancer patients using this modality and have seen improved swallow function in 9/15 patients. This is extremely promising and supports the need for a randomized clinical trial. The randomized controlled trial (RCT) proposed here will compare NMES therapy combined with exercise therapy to a sham NMES protocol combined with the same exercise therapy. These therapies will be given to post-radiated H&N cancer patients who have moderate to severe dysphagia at least 3 months post-XRT (or post-XRT + post-CRT), to determine whether NMES is efficacious. Therapy will continue for 12 weeks with an intense, daily home program. Objective indicators of a change in swallow function will be taken from modified barium swallow (MBS) studies. Subjective measures of change will be the patients' self-reported diet, eating ability, and quality of life, and will indicate whether they perceived a benefit from the therapy. This new treatment may represent the first real hope for improved swallowing in this growing population of cancer survivors. We need to determine whether it represents a truly beneficial treatment or whether our resources should be redirected. If successful, this study will stimulate a multitude of additional research to elucidate the mechanisms underlying this new treatment.
Interventions
DEVICENeurotech NT2000 Neuromuscular Electrical Stimulation (NMES)
NMES or Sham NMES will be paired with repeated, effortful swallowing behavior, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
Sponsors
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)
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ages 21+ * At least 3 months post-radiation therapy for head & neck cancer * Treatment for their cancer can include chemotherapy. * Surgery for their cancer, if done, must meet these criteria: * diagnostic biopsy * less than ½ of oral tongue resected * less than ½ of tongue base resected * no floor of mouth muscles resected * less than 50% of any other part of the oral cavity, pharynx or larynx resected * no resection of hyoid * Neck dissection, unilateral or bilateral neck dissections may have been completed prior to or after radiation therapy. * Currently free of cancer, confirmed by head and neck exam within 2 months of beginning the study * MBS demonstrates penetration or aspiration on at least one swallow during the study (minimum PAS = 4) * The patient is free of any medical conditions that could limit the patient's ability to follow the protocol. * No history of any swallowing problems prior to the onset of head and neck cancer * Prior swallow therapy, if given to the patient, is neither an Inclusion nor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Penetration-Aspiration Scale (PAS) Score | Before and after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI) | Before and after treatment | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Active NMES Group NMES therapy combined with exercise therapy | 116 |
| Sham NMES Group Sham NMES combined with exercise therapy | 54 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | HNC Recurrence | 4 | 0 |
| Overall Study | Lost to Follow-up | 4 | 5 |
| Overall Study | Needed Esophageal Dilation | 4 | 1 |
| Overall Study | Other CA Requiring Treatment | 1 | 3 |
| Overall Study | Unknown Reason | 2 | 2 |
| Overall Study | Unrelated Medical Complications | 3 | 1 |
| Overall Study | Withdrawal by Subject | 11 | 8 |
Baseline characteristics
| Characteristic | Active NMES Group | Sham NMES Group | Total |
|---|---|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 9.2 | 61.5 years STANDARD_DEVIATION 10.6 | 61.9 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 116 participants | 54 participants | 170 participants |
| Sex: Female, Male Female | 16 Participants | 9 Participants | 25 Participants |
| Sex: Female, Male Male | 100 Participants | 45 Participants | 145 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 116 | 7 / 54 |
| serious Total, serious adverse events | 14 / 116 | 5 / 54 |
Outcome results
Primary
Change in Penetration-Aspiration Scale (PAS) Score
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active NMES + Swallowing Exercise | Change in Penetration-Aspiration Scale (PAS) Score | 0.01 Change in points on PAS | Standard Deviation 1.04 |
| Sham (Inactive) NMES + Swallowing Exercise | Change in Penetration-Aspiration Scale (PAS) Score | -0.57 Change in points on PAS | Standard Deviation 1.62 |
Secondary
Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active NMES + Swallowing Exercise | 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 |
| Active NMES + Swallowing Exercise | 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 |
| Sham (Inactive) NMES + Swallowing Exercise | Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI) | Change in Total PSS score | 4.52 Change in PSS and HNCI score | Standard Deviation 16.06 |
| Sham (Inactive) NMES + Swallowing Exercise | Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI) | Change in HNCI Eating Domain | 6.74 Change in PSS and HNCI score | Standard Deviation 15.59 |