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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629265
• Other study ID #: H-26283
• Secondary ID: 5R01CA120950
• Status: Completed
• Phase: N/A
• First received: January 30, 2008
• Last updated: October 29, 2014
• Start date: March 2008
• Est. completion date: May 2013

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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.

Locations

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

Sponsors (16)

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

Country where clinical trial is conducted

United States, 

Outcome

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