UnknownPhase 1/2

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

Canada35 participantsStarted 2012-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. present with dysphagia symptoms
✓. with no evidence of residue cancer
✓. are within 3 months (but past 1 month) after treatment completion
✓. show positive dysphagia (EAT-10 score of \> 3) and/ or aspiration on barium swallow study
✓. are over 18 years old
✓. are able to read and write fluent English
✓. can give informed consent

Exclusion criteria

✕. have unstable heart disease
✕. have infectious disease transmissible by blood or body fluid, including hepatitis and HIV
✕. have skin disease at site of study acupuncture points that prevents the application of electrodes

What they're measuring

Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline

Timeframe: 3 months after treatment completion

Trial details

NCT IDNCT01697891

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09

View on ClinicalTrials.gov More Head and Neck Cancer trials