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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline
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.
3 months after treatment completion
No
Raimond Wong, MD
Principal Investigator
McMaster University
Canada: Ethics Review Committee
MU12-530
NCT01697891
October 2012
December 2013
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