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

Head and Neck Neoplasms Clinical Trial

— LEONIDAS-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941276
• Other study ID #: 11/0138
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: November 2014

Study information

• Verified date: October 2021
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Xerostomia

Intervention

Device:
• Active Electrostimulator device
Patients who will receive a fully functioning device
• Sham Electrostimulator device
Patients who will receive a device that does not release electric stimuli (but provided mechanical/tactile stimulation)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Salivary function	Improvement of objective salivary function as measured through 5-minutes sialometry	12 month
Secondary	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
Secondary	Oral Health Quality of Life	Improvement in oral health quality of life as measured on the OH-QoL16 questionnaire	12 month
Secondary	General quality of Life	Improvement in general quality of life as measured on the SF-36 questionnaire	12 month
Secondary	Participant compliance	Evaluation of patients' tolerance in using the device by using a diary to record daily measurement.	12 month