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ALTENS for Swallowing Difficulty
Phase 1 & 2
Waitlist Available
Led By Raimond Wong, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after treatment completion
Awards & highlights
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.
Eligible Conditions
- Swallowing Difficulty
- Head and Neck Cancers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after treatment completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after treatment completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline
Secondary outcome measures
Change in M. D. Anderson dysphagia inventory from baseline
Trial Design
1Treatment groups
Experimental Treatment
Group I: ALTENSExperimental Treatment1 Intervention
Patients in this arm will be treated with Acupuncture-like Transcutaneous Electrical Nerve Stimulation using Codetron (Codetron ALTENS)
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Who is running the clinical trial?
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
300,966 Total Patients Enrolled
McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,851 Total Patients Enrolled
Raimond Wong, MDPrincipal InvestigatorMcMaster University
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