Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Stefano Fedele
ORCID ID
Contact details
Eastman Dental Institute
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
+44 207 915 1004
s.fedele@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10229
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
Acronym
LEONIDAS2
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network, Oral and Gastrointestinal; Subtopic: Head and Neck Cancer, Oral and Gastrointestinal (all Subtopics); Disease: Head and Neck, Oral & Dental
Intervention
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
Device
Phase
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
01/11/2011
Overall trial end date
01/11/2014
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
01/11/2011
Recruitment end date
01/11/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Eastman Dental Institute
London
WC1X 8LD
United Kingdom
Sponsor information
Organisation
University College London Hospitals NHS Foundation Trust (UK)
Sponsor details
The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
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