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

NCT01697891 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2012-10-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Raimond Wong, MD · McMaster University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01697891 on ClinicalTrials.gov