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Effectiveness of Acupuncture-like Transcutaneous Nerve Stimulation (ALTENS) in Improving Dysphagia and Associated Symptoms of Chemotherapy and/or Intensity Modulated Radiation Therapy (IMRT) for Head and Neck Cancers: A Pilot Study


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Both
Head and Neck Cancer, Dysphagia

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Trial Information

Effectiveness of Acupuncture-like Transcutaneous Nerve Stimulation (ALTENS) in Improving Dysphagia and Associated Symptoms of Chemotherapy and/or Intensity Modulated Radiation Therapy (IMRT) for Head and Neck Cancers: A Pilot Study


Difficulty in swallowing is a concerning symptom after radiation treatment for some types of
head and neck cancers. Swallowing becomes difficult when radiation damage induces
inflammation (with swelling and pain) in the inner covering tissues of the throat and
muscles that involve in the swallowing process. Currently, supportive measures are used to
manage this symptom while waiting for the tissue damages to heal. In some patients, the
inflamed muscles develop scar tissues causing long-term swallowing difficulty and narrowing
of the swallowing passage. Needle acupuncture may help to reduce tissue inflammation and may
lessen the severity of swallowing difficulty. However, needle puncture is often not desired
by patients. Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) is like
acupuncture treatment, but the acupuncture points are stimulated with mild electrical
stimulation without needles, simplifying treatment delivery. This study is to examine if a
pre-selected set of acupuncture points treated using ALTENS can reduce swallowing
difficulty. There will be a total of 12 treatments given over 6 to 8 weeks. Changes in
severity of swallowing difficult after treatment will be assessed using 2 subjective
assessment tools.


Inclusion Criteria:

This study will recruit patients with head and neck cancers treated
with radiation+/- chemotherapy and who meet the following criteria (EAT-10 assessment will
be used for screening):

Inclusion Criteria

1. present with dysphagia symptoms

2. with no evidence of residue cancer

3. are within 3 months (but past 1 month) after treatment completion

4. show positive dysphagia (EAT-10 score of > 3) and/ or aspiration on barium swallow
study

5. are over 18 years old

6. are able to read and write fluent English

7. can give informed consent

Exclusion Criteria:

1. have unstable heart disease

2. have infectious disease transmissible by blood or body fluid, including hepatitis
and HIV

3. have skin disease at site of study acupuncture points that prevents the application
of electrodes

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline

Outcome Description:

EAT-10 is a self-administered questionnaire for subjective assessment of dysphagia. It consists of 10 items and each item is scored using a 5-point Likert scale. The higher the point, the more severe the problem being scored. Normative data suggested that a total score of 3 or higher is abnormal.

Outcome Time Frame:

3 months after treatment completion

Safety Issue:

No

Principal Investigator

Raimond Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McMaster University

Authority:

Canada: Ethics Review Committee

Study ID:

MU12-530

NCT ID:

NCT01697891

Start Date:

October 2012

Completion Date:

December 2013

Related Keywords:

  • Head and Neck Cancer
  • Dysphagia
  • Radiation Treatment
  • Head and Neck Cancer
  • Dysphagia
  • Deglutition Disorders
  • Head and Neck Neoplasms

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