Head and neck cancer patients have a better chance of survival in the 21st century because radiation therapy (RT), either alone or in combination with surgery and/or chemotherapy (CRT) 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 a 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 H&N 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 RCT proposed here will compare NMES therapy combined with traditional exercise therapy to a sham NMES protocol combined with the same exercise therapy, given to post-radiated H&N cancer patients who have moderate to severe dysphagia 3 to 6 months post-XRT, to determine whether NMES is efficacious. Therapy will continue for 12 weeks with an aggressive, daily home program. Objective indicators of a change in swallow function will be taken from fluoroscopy studies. Subjective measures of change will be the patient's self-reported diet, eating ability, and quality of life to 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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA120950-04
Application #
7845618
Study Section
Motor Function, Speech and Rehabilitation Study Section (MFSR)
Program Officer
Timmer, William C
Project Start
2007-07-01
Project End
2012-05-31
Budget Start
2010-06-01
Budget End
2011-05-31
Support Year
4
Fiscal Year
2010
Total Cost
$544,784
Indirect Cost
Name
Boston Medical Center
Department
Type
DUNS #
005492160
City
Boston
State
MA
Country
United States
Zip Code
02118
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