Dysphagia Clinical Trial
Official title:
Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Verified date | October 2014 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | May 2013 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Greater Baltimore Medical Center | Baltimore | Maryland |
United States | Lahey Clinic | Burlington | Massachusetts |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Northwestern University | Evanston | Illinois |
United States | University of Wisconsin | Madison | Wisconsin |
United States | Mout Sinai Medical Center | New York | New York |
United States | New York University | New York | New York |
United States | Beth Israel Medical Center | New York City | New York |
United States | Lenox Hill Hospital | New York City | New York |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of California, San Diego | San Diego | California |
United States | Mayo Clinic | Scottsdale | Arizona |
United States | University of Washington | Seattle | Washington |
United States | VA Boston Healthcare | West Roxbury | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | Beth Israel Medical Center, Boston University, Greater Baltimore Medical Center, Henry Ford Hospital, Icahn School of Medicine at Mount Sinai, Lahey Clinic, Lenox Hill Hospital, Mayo Clinic, National Cancer Institute (NCI), New York University, Northwestern University, University of California, San Diego, University of Washington, University of Wisconsin, Madison, VA Boston Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Penetration-Aspiration Scale (PAS) Score | The PAS scale is a validated 8-point ordinal scale (Rosenbek et. al 1996) in which a score of 1 is best (material does not enter the airway) and a score of 8 is worst (material enters the airway, passes below the vocal folds, and no effort is made to eject it). Difference in mean PAS scores after 12 weeks of therapy was analyzed between the two groups of interest: Active NMES + Swallowing Exercise versus Sham (inactive) NMES + Swallowing Exercise. PAS scores were obtained from fluoroscopy (modified barium swallow) studies adminstered at three time points - enrollment, midway through treatment (6 weeks), and at end of treatment (12 weeks). All fluoroscopy studies were sent to, and analyzed by, a blinded external central laboratory. |
Before and after treatment | Yes |
Secondary | Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI) | Perceive improved in quality of life and eating ability as measured by 2 validated scales: the Performance Status Scale for Head and Neck Cancer Patients (PSS) and The Head and Neck Cancer Inventory (HNCI). The PSS (List, et. al., 1990) is a clinician adminsitered scale that has three domains (normalcy of diet, eating in public, and understandability of speech). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best. The HNCI (Funk, et. al., 2003) is patient administered questionnaire that has four domains (social disruption, aesthetics, speech, eating). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best. |
Before and after treatment | No |
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