CompletedNot Applicable

A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer

84 participantsStarted 2011-11

Plain-language summary

This trial is looking at using an intra-oral electrostimulating device for the management of radiotherapy-induced dry mouth.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. To be at least 18 years old
✓. To have received more than 40 Gy of external beam RT for cancer in the H\&N region at least 4 months before entry into the study
✓. To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema
✓. To have a degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm VAS scale (0=no dryness; 100
✓. To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax)
✓. To have at least one parotid gland

✕. To have severe uncontrolled systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASA IV and ASA V)
✕. To have known allergy to materials similar to those used in the investigational product
✕. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids
✕. To have an unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow as measured via sialometry for 15 minutes).
✕. To use of pilocarpine as systemic therapy
✕. To have grade 3 RTOG/EROTC or no resting saliva (sialometry = 0mL/1.5 min)
✕. To have no parotid glands

Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale

Timeframe: 12 month

NCT IDNCT02941276

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11