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A Pilot Study of ALTENS in Improving Dysphagia Induced by IMRT for Head and Neck Cancers

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Raimond Wong, McMaster University
ClinicalTrials.gov Identifier:
NCT01697891
First received: September 26, 2012
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Head and Neck Cancer
Dysphagia
 Device: Codetron ALTENS
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline [ Time Frame: 3 months after treatment completion ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in M. D. Anderson dysphagia inventory from baseline [ Time Frame: 3 months after treatment completion ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 35
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALTENS
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697891

Locations
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V5C2
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Raimond Wong, MD McMaster University
  More Information

No publications provided

Responsible Party: Raimond Wong, Associate Professor, Department of Oncology, McMaster University
ClinicalTrials.gov Identifier: NCT01697891     History of Changes
Other Study ID Numbers: MU12-530
Study First Received: September 26, 2012
Last Updated: October 1, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Radiation Treatment
Head and Neck Cancer
Dysphagia

Additional relevant MeSH terms:
Deglutition Disorders
Head and Neck Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Pharyngeal Diseases
Otorhinolaryngologic Diseases
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013