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

21 Years
Open (Enrolling)

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Trial Information

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

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

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.

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

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Reduction of aspiration as measured on the Penetration-Aspiration Scale from the fluoroscopy studies done.

Outcome Time Frame:

Before and after treatment

Safety Issue:


Principal Investigator

Susan Langmore, PhD,SLP,BRS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston University


United States: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

December 2012

Related Keywords:

  • Dysphagia
  • Dysphagia
  • Neuromuscular Electrical Stimulation (NMES)
  • Head & Neck Cancer
  • Radiation and ChemoTherapy
  • Deglutition Disorders
  • Head and Neck Neoplasms



Mayo Clinic Rochester, Minnesota  55905
Henry Ford Hospital Detroit, Michigan  48202
Beth Israel Medical Center New York, New York  10003
Greater Baltimore Medical Center Baltimore, Maryland  21204
University of Washington Seattle, Washington  98195
Northwestern University Chicago, Illinois  60611
Lahey Clinic Burlington, Massachusetts  01805
Mayo Clinic Scottsdale, Arizona  
University of California, San Diego La Jolla, California  92037-1709
New York University New York, New York  10016
University of Wisconsin Madison,, Wisconsin  53792-5666
VA Boston Healthcare West Roxbury, Massachusetts  02132
Mout Sinai Medical Center New York, New York  10029
Lenox Hill Hospital New York City, New York  10021