DysphagiaNCT00629265
Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
A study testing Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) in people with Dysphagia, run by Boston Medical Center at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 14 sitesUnited States
- Study dates
- Mar 2008to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 Exclusion criteria
Who cannot join
- Inability to cooperate with the examination and treatment.
- An implanted electrical device (e.g., pacemaker, deep brain stimulator, defibrillator, vagal nerve stimulator)
- Previous e-stim treatment to the head \& neck
- Any current or previous neurological disease which may adversely affect swallowing.
- History of oropharyngeal swallowing disorder prior to cancer.
- History of pre-cancer oral intake that was limited due to a swallowing problem.
Show all 11Show fewer
- Previous neurosurgery on the brain that could compromise swallowing or ability to follow protocol.
- Severe COPD (oxygen dependent).
- Need for dilation of the upper esophageal sphincter or esophagus at time of entry.
- Females who are currently pregnant will be excluded from participation.
- Females of childbearing potential must have a negative pregnancy test and must be practicing a medically accepted means of contraception (including, but not limited to, condoms, diaphragms/caps, contraceptive pills, contraceptive rings/patches, intrauterine devices, hysterectomy or abstinence)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Lahey Clinic
Burlington, Massachusetts, 01805
Henry Ford Hospital
Detroit, Michigan, 48202
Northwestern University
Evanston, Illinois, 60208
University of Wisconsin
Madison, Wisconsin, 53792
Beth Israel Medical Center
New York, New York, 10003
New York University
New York, New York, 10016
Lenox Hill Hospital
New York, New York, 10021
Mout Sinai Medical Center
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Diego
San Diego, California, 92103
Mayo Clinic
Scottsdale, Arizona, 85259
University of Washington
Seattle, Washington, 98195
VA Boston Healthcare
West Roxbury, Massachusetts, 02132
About this study
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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)
- Keywords
- Dysphagia, Neuromuscular Electrical Stimulation (NMES), Head & Neck Cancer, Radiation and ChemoTherapy
- Medical subject headings
- Deglutition Disorders, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)Device
Also called E-Stim, Neurotech NT2000
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.
| Study group | Role | What they receive |
|---|---|---|
| Active NMES + Swallowing Exercise | Active comparator | Active Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks. Receives: Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) |
| Sham NMES + Swallowing Exercise | Sham comparator | Sham (inactive) Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks. Receives: Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after treatment
Secondary outcomes (1)
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.
Measured: Before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Principal investigator, Susan Langmore, Boston Medical Center
- Investigators
- Susan Langmore, PhD,SLP,BRS, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629265
- Sponsor's protocol ID
- H-26283
- Other IDs
- 5R01CA120950
- Status last verified
- Oct 2014
- First submitted
- 30 Jan 2008
- Last updated
- 31 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT00629265
- Acronym / sponsor ID
- H-26283
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Neuromuscular Electrical Stimulation (NMES), Head & Neck Cancer, Radiation and ChemoTherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- 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)
- Study start
- Mar 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Posted 31 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active NMES + Swallowing Exercise | Active comparator | Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)Active Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks. |
| Sham NMES + Swallowing Exercise | Sham comparator | Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)Sham (inactive) Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Currently free of cancer, confirmed by head and neck exam within 2 months of beginning the study
Key exclusion criteria (11 listed)
- Inability to cooperate with the examination and treatment.
- An implanted electrical device (e.g., pacemaker, deep brain stimulator, defibrillator, vagal nerve stimulator)
- Previous e-stim treatment to the head \& neck
- Any current or previous neurological disease which may adversely affect swallowing.
- History of oropharyngeal swallowing disorder prior to cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)Also: E-Stim, Neurotech NT2000NMES 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. | Device | Active NMES + Swallowing Exercise, Sham NMES + Swallowing Exercise |
Primary outcome
Change in Penetration-Aspiration Scale (PAS) Score
Time frame: 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.
1 secondary outcome
Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)
Time frame: Before and after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Langmore, PhD,SLP,BRS principal investigator
Boston University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) in people with Dysphagia, run by Boston Medical Center at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Penetration-Aspiration Scale (PAS) Score (time frame: Before and after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.