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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Boston Medical Center.
Recruitment status was  Active, not recruiting
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
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Susan Langmore, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00629265
First received: January 30, 2008
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Dysphagia
Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Reduction of aspiration as measured on the Penetration-Aspiration Scale from the fluoroscopy studies done. [ Time Frame: Before and after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
NMES therapy combined with exercise therapy
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
Sham Comparator: 2
Sham NMES combined with exercise therapy
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629265

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
University of California, San Diego
San Diego, California, United States, 92103
United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
VA Boston Healthcare
West Roxbury, Massachusetts, United States, 02132
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
New York University
New York, New York, United States, 10016
Mout Sinai Medical Center
New York, New York, United States, 10029
Beth Israel Medical Center
New York City, New York, United States, 10003
Lenox Hill Hospital
New York City, New York, United States, 10021
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Boston Medical Center
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
Mount Sinai School of Medicine
Investigators
Principal Investigator: Susan Langmore, PhD,SLP,BRS Boston University
  More Information

Additional Information:
No publications provided

Responsible Party: Susan Langmore, Director, Speech Language Pathology, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00629265     History of Changes
Other Study ID Numbers: H-26283, 1 R01 CA120950-01 A1
Study First Received: January 30, 2008
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Dysphagia
Neuromuscular Electrical Stimulation (NMES)
Head & Neck Cancer
Radiation and ChemoTherapy

Additional relevant MeSH terms:
Deglutition Disorders
Head and Neck Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014