Clinical trial NCT00629265: Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Official title: Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Dysphagia
Neuromuscular Electrical Stimulation (NMES)
Head & Neck Cancer
Radiation and ChemoTherapy
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Boston University
name: University of Wisconsin, Madison
name: New York University
name: VA Boston Healthcare System
name: Lahey Clinic
name: Lenox Hill Hospital
name: Beth Israel Medical Center
name: Greater Baltimore Medical Center
name: Henry Ford Hospital
name: University of California, San Diego
name: University of Washington
name: Mayo Clinic
name: Icahn School of Medicine at Mount Sinai
name: National Cancer Institute (NCI)
First posted: 2008-03-05
Enrollment: 170
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Change in Penetration-Aspiration Scale (PAS) Score
timeFrame: Before and after treatment
Secondary outcomes:
measure: Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)
timeFrame: Before and after treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: West Roxbury
country: United States
facility: VA Boston Healthcare
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York City
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York City
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Mout Sinai Medical Center
state: New York
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Boston University
name: Susan Langmore, PhD,SLP,BRS
role: PRINCIPAL_INVESTIGATOR
References: