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

Not Applicable

Completed

Conditions: Dysphagia

Interventions: Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)

Registration Number: NCT00629265

Lead Sponsor: Boston Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 170

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 Exclusion criteria

Exclusion Criteria

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.
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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham NMES + Swallowing Exercise	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.
Active NMES + Swallowing Exercise	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (13): University of California, San Diego
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San Diego, California, United States
Northwestern University
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Evanston, Illinois, United States
Lenox Hill Hospital
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New York City, New York, United States
Beth Israel Medical Center
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New York City, New York, United States
University of Wisconsin
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Madison, Wisconsin, United States
VA Boston Healthcare
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West Roxbury, Massachusetts, United States
Lahey Clinic
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Burlington, Massachusetts, United States
University of Washington
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Seattle, Washington, United States
New York University
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New York, New York, United States
Mout Sinai Medical Center
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New York, New York, United States
Greater Baltimore Medical Center
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Baltimore, Maryland, United States
Mayo Clinic
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Rochester, Minnesota, United States
Henry Ford Hospital
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Detroit, Michigan, United States