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