XerostomiaLEONIDAS-2NCT02941276

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

A study testing Active Electrostimulator device in people with Xerostomia and Head and Neck Neoplasms, run by University College, London.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Xerostomia, Head and Neck Neoplasms
What is being tested?: Active Electrostimulator device
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: No sites listed yet
Study dates: Nov 2011to Nov 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
=maximum dryness).
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

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Conditions: Xerostomia, Head and Neck Neoplasms
Being tested: Active Electrostimulator device, Sham Electrostimulator device
Medical subject headings: Xerostomia, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02941276
Study group	Role	What they receive
Group A	Experimental	Active electrostimulator device (intra-oral active second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel) Receives: Device: Active Electrostimulator device
Group B	Sham comparator	Sham electrostimulator device (intra-oral sham second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel) Receives: Device: Sham Electrostimulator device

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 month

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Nov 2014

First posted21 Oct 2016 (estimated)
Study startNov 2011
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for XerostomiaStudies of the same condition, open and under way.
More trials run by University College, LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02941276
Sponsor's protocol ID: 11/0138
Acronym: LEONIDAS-2
Status last verified: Oct 2021
First submitted: 12 Oct 2016
Last updated: 3 Nov 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Xerostomia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Evaluation of the Effectiveness Of a Novel Intra-oral Electro-stimulator for the Treatment of raDiotherapy-ASsociated Dry Mouth
ClinicalTrials.gov ID: NCT02941276
Acronym / sponsor ID: LEONIDAS-2 / 11/0138
Conditions: Xerostomia, Head and Neck Neoplasms
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: University College, LondonUniversity, hospital or other
Study start: Nov 2011
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 21 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Device: Active Electrostimulator deviceActive electrostimulator device (intra-oral active second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)
Group B	Sham comparator	Device: Sham Electrostimulator deviceSham electrostimulator device (intra-oral sham second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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
=maximum dryness).

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active Electrostimulator devicePatients who will receive a fully functioning device	Device	Group A
Sham Electrostimulator devicePatients who will receive a device that does not release electric stimuli (but provided mechanical/tactile stimulation)	Device	Group B

Primary outcome

Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale
Time frame: 12 month
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).

5 secondary outcomes

Salivary function
Time frame: 12 month
Head and Neck cancer Quality of Life
Time frame: 12 month
Oral Health Quality of Life
Time frame: 12 month
General quality of Life
Time frame: 12 month
Participant compliance
Time frame: 12 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
Individual participant dataSharing planned: No

Related trials for Xerostomia

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr Stefano Fedele, PhD principal investigator

University College, London

Questions about this trial

What is this clinical trial studying?

A study testing Active Electrostimulator device in people with Xerostomia and Head and Neck Neoplasms, run by University College, London.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02941276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.