A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer (LEONIDAS-2)

Long-term Evaluation of the Effectiveness Of a Novel Intra-oral Electro-stimulator for the Treatment of raDiotherapy-ASsociated Dry Mouth

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

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms; Xerostomia
• Intervention / Treatment: Device: Active Electrostimulator device; Device: Sham Electrostimulator device

Detailed Description

Dry mouth is a common complaint of radiotherapy for cancer of the head and neck region. It is a distressing often persistent condition which can lead to longlasting oral discomfort, dental infections, diminished quality of life, social isolation and loneliness. Unfortunately, current therapies of dry mouth are often unsatisfactory, expensive and may result in adverse effects. A novel intraoral electronic device has recently been developed to treat dry mouth. The device, acting as a "salivary pacemaker", harmlessly stimulates nerves of the salivary glands and does not cause adverse side effects. The aim of this proposal is to assess the longterm effects of such a device in this population, which have yet to be investigated, to demonstrate whether its daily application is an effective method of lessening dry mouth and improving life quality. 84 individuals will be enrolled in the study to use the device for 12 months, after receiving appropriate instructions. 42 participants (out of 84) will act as controls as they will receive a sham device that will not deliver electric stimuli but only tactile stimulation (like using a chewing gum). All participants will be allowed to continue using their routine local therapy for dry mouth (e.g. artificial saliva) during the study. Each participant will keep a diary relevant to the frequency of use and potential changes in dry mouth sensation. Participants will also be asked to attend hospital appointments to measure changes in saliva production and complete questionnaires on their dry mouth and quality of life. The device has the potential to radically change current clinical practice. If the trial is successful, the use of the device will provide patients having radiation-induced dry mouth with a safe and drug-free therapeutic modality.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. To be at least 18 years old
2. 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
3. To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema

4. To have a degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Active electrostimulator device (intra-oral active second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)	Device: Active Electrostimulator device; Patients who will receive a fully functioning device
Sham Comparator: Group B; Sham electrostimulator device (intra-oral sham second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)	Device: Sham Electrostimulator device; Patients who will receive a device that does not release electric stimuli (but provided mechanical/tactile stimulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale	The primary outcome is defined as the proportion of patients reporting a 30% reduction of xerostomia symptoms as evaluated through a 100mm VAS (100mm=maximum dryness).	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary function	Improvement of objective salivary function as measured through 5-minutes sialometry	12 month
Head and Neck cancer Quality of Life	Improvement in head and neck quality of life as measured on the EORTC QLQ-H&N35	12 month
Oral Health Quality of Life	Improvement in oral health quality of life as measured on the OH-QoL16 questionnaire	12 month
General quality of Life	Improvement in general quality of life as measured on the SF-36 questionnaire	12 month
Participant compliance	Evaluation of patients' tolerance in using the device by using a diary to record daily measurement.	12 month

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Dr Stefano Fedele, PhD, University College, London

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Head and Neck Neoplasms; Xerostomia
• Other Study ID Numbers: 11/0138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No