Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00629265
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Collaborators:
Northwestern University
Boston University
University of Wisconsin, Madison
New York University
VA Boston Healthcare System
Lahey Clinic
Lenox Hill Hospital
Beth Israel Medical Center
Greater Baltimore Medical Center
Henry Ford Hospital
University of California, San Diego
University of Washington
Mayo Clinic
Icahn School of Medicine at Mount Sinai
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Susan Langmore, Boston Medical Center

Tracking Information
First Submitted Date  ICMJE January 30, 2008
First Posted Date  ICMJE March 5, 2008
Results First Submitted Date  ICMJE August 28, 2013
Results First Posted Date  ICMJE October 31, 2014
Last Update Posted Date October 31, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
Change in Penetration-Aspiration Scale (PAS) Score [ Time Frame: Before and after treatment ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2008)
Reduction of aspiration as measured on the Penetration-Aspiration Scale from the fluoroscopy studies done. [ Time Frame: Before and after treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI) [ Time Frame: Before and after treatment ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2008)
Perceive improved quality of life as measured by 2 validated scales: the Performance Status Scale for Head and Neck Cancer Patients and The Head and Neck Cancer Inventory (HNCI) which contain domains centered around eating, diet and social interaction. [ Time Frame: Before and after treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Official Title  ICMJE Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
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 currently have dysphagia swallow better.
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 therapy has a high rate of local / regional control, and may extend duration of life. Unfortunately the elimination of the cancer can leave devastating side effects, including the inability to eat and swallow normally. Organ preservation, often assumed to be the preferred treatment, has now been shown to magnify dysphagia. Incidence of dysphagia in this group of patients is extremely high, with symptoms continuing to deteriorate for several years after treatment. Conventional therapy for dysphagia yields only minor benefit. Persistence of dysphagia has a major impact on the quality of life of these cancer survivors.

Recently, a new therapy approach has been introduced for dysphagia, called e-stim or Neuromuscular Electrical Stimulation (NMES). Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction. An aggressive marketing campaign has turned e-stim into a very popular and sought-after therapy for dysphagia. However, there are no efficacy studies demonstrating its true benefit.

We have collected preliminary data with Head & Neck cancer patients using this modality and have seen improved swallow function in 9/15 patients. This is extremely promising and supports the need for a randomized clinical trial. The randomized controlled trial (RCT) proposed here will compare NMES therapy combined with exercise therapy to a sham NMES protocol combined with the same exercise therapy.

These therapies will be given to post-radiated H&N cancer patients who have moderate to severe dysphagia at least 3 months post-XRT (or post-XRT + post-CRT), to determine whether NMES is efficacious. Therapy will continue for 12 weeks with an intense, daily home program. Objective indicators of a change in swallow function will be taken from modified barium swallow (MBS) studies. Subjective measures of change will be the patients' self-reported diet, eating ability, and quality of life, and will indicate whether they perceived a benefit from the therapy.

This new treatment may represent the first real hope for improved swallowing in this growing population of cancer survivors. We need to determine whether it represents a truly beneficial treatment or whether our resources should be redirected. If successful, this study will stimulate a multitude of additional research to elucidate the mechanisms underlying this new treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dysphagia
Intervention  ICMJE Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)
NMES or Sham NMES will be paired with repeated, effortful swallowing behavior, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
Other Names:
  • E-Stim
  • Neurotech NT2000
Study Arms  ICMJE
  • Active Comparator: Active NMES + Swallowing Exercise
    Active Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks.
    Intervention: Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)
  • Sham Comparator: Sham NMES + Swallowing Exercise
    Sham (inactive) Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks.
    Intervention: Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2014)
170
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2008)
240
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00629265
Other Study ID Numbers  ICMJE H-26283
5R01CA120950 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Langmore, Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE
  • Northwestern University
  • Boston University
  • University of Wisconsin, Madison
  • New York University
  • VA Boston Healthcare System
  • Lahey Clinic
  • Lenox Hill Hospital
  • Beth Israel Medical Center
  • Greater Baltimore Medical Center
  • Henry Ford Hospital
  • University of California, San Diego
  • University of Washington
  • Mayo Clinic
  • Icahn School of Medicine at Mount Sinai
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Susan Langmore, PhD,SLP,BRS Boston University
PRS Account Boston Medical Center
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP