Status:
COMPLETED
Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
Northwestern University
Boston University
Conditions:
Dysphagia
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 therap...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00629265
Start Date
March 1 2008
End Date
May 1 2013
Last Update
October 31 2014
Active Locations (14)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
University of California, San Diego
San Diego, California, United States, 92103
3
Northwestern University
Evanston, Illinois, United States, 60208
4
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204