ong-term Evaluation of the effectiveness Of a Novel Intra-oral electro-stimulator for the treatment of raDiotherapy-ASsociated dry mouth (The LEONIDAS-2 study): a randomised controlled trial

niversity College London Hospitals NHS Foundation Trust (UK)0 sites84 target enrollmentOctober 28, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 28, 2011

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity College London Hospitals NHS Foundation Trust (UK)

•1\. To be at least 18 years old
•2\. To have received more than 40 Gy of external beam radiotherapy (RT) for cancer in the head and neck region at least 4 months before entry into the study
•3\. To have grade 1 or 2 of Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema
•4\. To have a degree of minimum degree of dryness of 50mm (\=50mm) on a 100mm Visual Analogue Scale (VAS) scale (0\=no dryness; 100\=maximum dryness)
•5\. To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax)
•6\. To have at least one parotid gland; Target Gender: Male \& Female ; Lower Age Limit 18 no age limit or unit specified

•1\. To have severe uncontrolled systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASA IV and ASA V)
•2\. To have known allergy to materials similar to those used in the investigational product
•3\. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids
•4\. To have an unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow as measured via sialometry for 15 minutes)
•5\. To use of pilocarpine as systemic therapy
•6\. To have grade 3 RTOG/EROTC or no resting saliva (sialometry \= 0mL/1\.5 min)
•7\. To have no parotid glands