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

NCT00629265 | Completed Results DMC

• 2 other identifiers: H-262835R01CA120950
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 14

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.

Conditions

Dysphagia

Keywords

Dysphagia; Neuromuscular Electrical Stimulation (NMES); Head & Neck Cancer; Radiation and ChemoTherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)

  Before and after treatment

Study Arms (2)

Active NMES + Swallowing Exercise

ACTIVE COMPARATOR

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.

Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)

Sham NMES + Swallowing Exercise

SHAM COMPARATOR

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.

Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)

Interventions

Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) DEVICE

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.

Also known as: E-Stim, Neurotech NT2000

Active NMES + Swallowing Exercise; Sham NMES + Swallowing Exercise

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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)

Sponsors & Collaborators

• Boston Medical Center: lead
• Northwestern University: collaborator
• Boston University: collaborator
• University of Wisconsin, Madison: collaborator
• New York University: collaborator
• VA Boston Healthcare System: collaborator
• Lahey Clinic: collaborator
• Lenox Hill Hospital: collaborator
• Beth Israel Medical Center: collaborator
• Greater Baltimore Medical Center: collaborator
• Henry Ford Hospital: collaborator
• University of California, San Diego: collaborator
• University of Washington: collaborator
• Mayo Clinic: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (14)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

VA Boston Healthcare

West Roxbury, Massachusetts, 02132, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

New York University

New York, New York, 10016, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

Mout Sinai Medical Center

New York, New York, 10029, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neoplasms by Site; Neoplasms

Limitations and Caveats

Because of funding limitations research assistants could not be hired at most sites, and so 170 (instead of 240) subjects were enrolled. However, the results suggest additional patients would not have changed the outcome.

Results Point of Contact

• Title: Dr. Susan Langmore, PhD, Director of Speech Language Pathology
• Organization: Boston Medical Center

langmore@bu.edu

617-414-1753

Study Officials

• Susan Langmore, PhD,SLP,BRS

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Speech Language Pathology

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: March 5, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2013
• Last Updated: October 31, 2014
• Results First Posted: October 31, 2014

Record last verified: 2014-10

Locations

US (14)