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
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.