Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Dysphagia

In brief

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 currently have dysphagia swallow better.

Key facts

Study ID

NCT00629265

Run by

Boston Medical Center

People needed

170

Starts

2008-03-01

Expected to finish

2013-05-01

Last updated by the study team

2014-10-31

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• University of California, San Diego — San Diego, California, United States
• Northwestern University — Evanston, Illinois, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• VA Boston Healthcare — West Roxbury, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Beth Israel Medical Center — New York, New York, United States
• New York University — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Mout Sinai Medical Center — New York, New York, United States
• University of Washington — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.