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

NCT ID: NCT01697891

Last Updated: 2012-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer Dysphagia

Keywords

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Radiation Treatment Head and Neck Cancer Dysphagia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ALTENS

Patients in this arm will be treated with Acupuncture-like Transcutaneous Electrical Nerve Stimulation using Codetron (Codetron ALTENS)

Group Type EXPERIMENTAL

Codetron ALTENS

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Raimond Wong

Associate Professor, Department of Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raimond Wong, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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MU12-530

Identifier Type: -

Identifier Source: org_study_id