Dysphagia Clinical Trial
Official title:
BION Stimulation to Improve Swallowing Function After Radical Head-neck Surgery and Follow-up Chemoradiation Therapy
The primary goal of the proposed study is to improve the long-term swallowing capabilities of subjects undergoing radical or modified radical neck surgeries followed by chemoradiation therapy (CRT), by more selective stimulation of the swallowing muscles using implanted microstimulators called BIONs.
Disseminated head and neck cancer is a serious, often life-threatening medical problem that
requires immediate and heroic therapeutic intervention. Treatment typically begins with
extensive surgery followed as soon as possible by an intense series of radiation and
chemotherapy treatments. Typically the patient has recovered sufficiently from the surgery
by 2-4 weeks to withstand the new assaults that will result from chemoradiation therapy
(CRT), which kills cancer cells, but also causes muscle atrophy and scarring that can
permanently ruin the swallowing apparatus. Thus, the majority of patients who undergo CRT
develop severe swallowing problems, called dysphagia, that typically becomes worse by about
3-4 weeks following the beginning of CRT. In anticipation of all of these problems, subjects
have a tube placed in the stomach (gastrostomy tube) so that they can be fed through the
tube in the immediate postoperative period when the incision is fragile and when dysphagia
develops during CRT. Clearly the management of dysphagia during CRT is of primary importance
to the prognosis of the patient. Recent studies have shown that electrical activation of
swallowing muscles during and after CRT can improve the prognosis by reducing dysphagia, but
currently available technology requires the current to be applied transcutaneously. Thus,
large electrical currents must be applied to the damaged skin, and the electrical
stimulation that results is uncomfortable, diffuse and uncontrolled. It is difficult with
this approach to stimulate the deepest muscles that are the preferred targets for the
stimulation. The primary goal of the proposed study is to improve the long-term swallowing
capabilities of subjects undergoing radical or modified radical neck surgeries followed by
CRT, by more selective stimulation of the swallowing muscles using implanted
microstimulators called BIONs. The mechanism of the electrical stimulation is thought to be
the same as that for other rehabilitative approaches to muscle, i.e.,to help maintain
strength and mobility of these muscles during the post-operative treatment period when the
muscles are not being used and are particularly vulnerable to scarring and atrophy.
Two different paradigms of stimulation will be employed in order to compare and gain insight
into the mechanisms involved in the remediation. This study also presents the opportunity to
examine directly the changes in muscle produced by stimulation. Thus, a secondary research
goal of the study that takes advantage of the opportunity presented by this intervention is
to gain insight into the cellular changes that are thought to underlie the effects of
radiation and subsequent electrical stimulation. By implanting these devices at the time of
the neck surgeries, it is possible to target the nerves that supply specific muscles and
thus ensure the excitation of specific muscles using current strengths much lower than those
required with transcutaneous stimulation.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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