A Pilot Study of ALTENS in Improving Dysphagia Induced by IMRT for Head and Neck Cancers
|ClinicalTrials.gov Identifier: NCT01697891|
Recruitment Status : Unknown
Verified October 2012 by Raimond Wong, McMaster University.
Recruitment status was: Enrolling by invitation
First Posted : October 2, 2012
Last Update Posted : October 2, 2012
Study hypothesis: ALTENS techniques, administered within the first 3 months after radiation completion, can improve radiation-induced dysphagia and associated symptoms in head and neck cancer patients. This beneficial effect is mediated by the reduction of chronic inflammatory response of swallowing musculature to radiation, consequently a reduction in muscle fibrosis.
Primary study objective: To evaluate the effectiveness of ALTENS in relieving radiation-induced dysphagia. Eating Assessment Tool (EAT-10) scores will be used for this primary study endpoint.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Dysphagia||Device: Codetron ALTENS||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||December 2013|
Patients in this arm will be treated with Acupuncture-like Transcutaneous Electrical Nerve Stimulation using Codetron (Codetron ALTENS)
Device: Codetron ALTENS
ALTENS stimulation of a set of selected acupuncture points for 20 minutes in each treatment. Two treatments per week for a total of 12 treatments to be delivered within 8 weeks.
- Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline [ Time Frame: 3 months after treatment completion ]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.
- Change in M. D. Anderson dysphagia inventory from baseline [ Time Frame: 3 months after treatment completion ]M. D. Anderson dysphagia inventory (MDADI) is a self-administered questionnaire designed specifically to assess the quality of life for head and neck cancer patients who suffer from dysphagia. It incorporated three domains: emotional, functional and physical, and one global question. There are a total of 20 items.Each item is scored on a scale of 1 to 5 with 1 being strongly agree and 5 strongly disagree except for two items, one on the emotional subscale and the other on the functional subscale. The global question is scored and interpreted separately. The scores of all the items in each domain are summed and a mean score is calculated. The final score for each subscale is calculated by multiplying the calculated mean score by 20 with a final range from 0 to 100. The final score of the global question is also calculated in the same way. The higher the final score represents better functioning and quality of life.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697891
|Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V5C2|
|Principal Investigator:||Raimond Wong, MD||McMaster University|