BION Treatment of Dysphagia After Radical Head-Neck Surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||BION Stimulation to Improve Swallowing Function After Radical Head-neck Surgery and Follow-up Chemoradiation Therapy|
- swallowing function [ Time Frame: prior surgery, 2w post surgery, end of radiation recovery, end of rehab ] [ Designated as safety issue: No ]
- blood test, ease of swallowing questionnaire [ Time Frame: prior surgery, 2w post surgery, end of radiation recovery, end of rahab ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Low Stimulation
The first group will have a stimulation paradigm employing low-frequency (1-5 pps), supramaximal "twitch" stimulation.
The first group will have a stimulation paradigm employing low-frequency (1-5 pps), supramaximal "twitch" stimulation. The period of the stimulation will probably be short for the first sessions as the muscles gain strength and fatigue resistance, but will eventually be 60 minutes per day in two spaced sessions of about 30 minutes each.
Experimental: High Stimulation
The second group will have a "High Stimulation" paradigm at a frequency that produces strong, fused contractions (20-30pps) for a total of 1h/d, also in two spaced sessions.
The second group will have a "High Stimulation" paradigm at a frequency that produces strong, fused contractions (20-30pps) for a total of 1h/d, also in two spaced sessions. Stimulation intensity will be adjusted to produce the strongest contractions that are tolerated.
Placebo Comparator: Control Group
A third group of experimental subjects will have a standardized program of voluntary swallowing exercises.
A third group of experimental subjects will have a standardized program of voluntary swallowing exercises. Their BIONs will not be activated until they have worsening of dysphagia, and thus are considered to have failed conventional therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628485
|United States, California|
|USC University Hospitals|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Gerald Loeb, MD||University of Southern California|