Condition category
Digestive System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Dr Stefano Fedele


Contact details

Eastman Dental Institute
256 Gray's Inn Road
United Kingdom
+44 207 915 1004

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Long-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



Study hypothesis

The main research question of this study is:

1. Will a new intra-oral removable device provide long-term relief of distressing symptoms of reduced salivation (dry mouth or xerostomia) resulting from radiotherapy to the Head and Neck?

Other research questions are:
1. Will the intra-oral removable device improve salivary gland function (increase of salivary flow) of patients who have hyposalivation resulting from radiotherapy (RT) to the Head and Neck?
2. Will the intra-oral removable device improve quality of life of patients who have dry mouth resulting from radiotherapy (RT) to the Head and Neck?
3. How frequently patients will use the new intra-oral removable device to lessen dry mouth symptoms resulting from radiotherapy (RT) to the Head and Neck?

Ethics approval

The Yorkshire & Humber Research Ethics Committee - Sheffield, ref: 11/YH/0072

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: National Cancer Research Network, Oral and Gastrointestinal; Subtopic: Head and Neck Cancer, Oral and Gastrointestinal (all Subtopics); Disease: Head and Neck, Oral & Dental


Assuming that 20% of the patients of the control group report the successful outcome (30%+ reduction in symptoms on the VAS) and 60% of patients on the active device will do so, the sample size required to detect such a difference in reduction of xerostomia symptoms with 90% power using a cutoff for statistical significance of p<0.05 is 70. Considering a potential drop out of 20%, the total number of patients to be enrolled is 84 (42 in the study group and 42 in the control group).

Salivary electrostimulation, Participants will be provided with a electrosimulating device to be applied in the mouth and used as symptoms dictate (max 10min/hour). Participants in the control group will receive a non-active device.; Follow Up Length: 12 month(s); Study Entry : Registration and One or More Randomisations

Intervention type



Phase II/III

Drug names

Primary outcome measure

VAS dry mouth score; Timepoint(s): Month 0 and 12 as part of follow-up appointments

Secondary outcome measures

1.Home diary; Timepoint(s): To record fequency of device application and weekly VAS dry mouth score
2. Quality of Life Measures; Timepoint(s): QoL questionnaires. Month 0, 1, 2, 4, 6, 8, 12 as part of follow up appointments
3. Salivary flow measurement; Timepoint(s): During month 0, 1, 2, 4, 6, 8, 12 of the trial as part of follow-up appointments

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Participant type


Age group




Target number of participants

Planned Sample Size: 84; UK Sample Size: 84

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Eastman Dental Institute
United Kingdom

Sponsor information


University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

The Hatter Institute for Cardiovascular Studies
25 Grafton Way
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/12/2016: No publications found in PubMed, verifying study status with principal investigator.