Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
NCT ID: NCT00629265
Last Updated: 2014-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2008-03-31
2013-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active NMES + Swallowing Exercise
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.
Neurotech 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.
Sham NMES + Swallowing Exercise
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.
Neurotech 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.
Interventions
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Neurotech 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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)
21 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Boston University
OTHER
University of Wisconsin, Madison
OTHER
New York University
OTHER
VA Boston Healthcare System
FED
Lahey Clinic
OTHER
Lenox Hill Hospital
OTHER
Beth Israel Medical Center
OTHER
Greater Baltimore Medical Center
OTHER
Henry Ford Hospital
OTHER
University of California, San Diego
OTHER
University of Washington
OTHER
Mayo Clinic
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
National Cancer Institute (NCI)
NIH
Boston Medical Center
OTHER
Responsible Party
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Susan Langmore
Director, Speech Language Pathology
Principal Investigators
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Susan Langmore, PhD,SLP,BRS
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
University of California, San Diego
San Diego, California, United States
Northwestern University
Evanston, Illinois, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Lahey Clinic
Burlington, Massachusetts, United States
VA Boston Healthcare
West Roxbury, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Beth Israel Medical Center
New York, New York, United States
New York University
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Mout Sinai Medical Center
New York, New York, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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H-26283
Identifier Type: -
Identifier Source: org_study_id
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