Study on a novel medical device for the treatment of reduced salivation (dry mouth) resulting from radiation therapy

ISRCTN	ISRCTN24437812
DOI	https://doi.org/10.1186/ISRCTN24437812
Secondary identifying numbers	10229

Submission date: 28/10/2011
Registration date: 28/10/2011
Last edited: 13/01/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-treating-dry-mouth-after-radiotherapy-head-and-neck-cancer-the-leonidas-2-study

Contact information

Dr Stefano Fedele
Scientific

Eastman Dental Institute
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom

Phone	+44 207 915 1004
Email	s.fedele@ucl.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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 acronym	LEONIDAS2
Study objectives	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(s)	The Yorkshire & Humber Research Ethics Committee - Sheffield, ref: 11/YH/0072
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II/III
Drug / device / biological / vaccine name(s)
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 study start date	01/11/2011
Completion date	01/11/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 84; UK Sample Size: 84
Key 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
Key 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
Date of first enrolment	01/11/2011
Date of final enrolment	01/11/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Eastman Dental Institute

London
WC1X 8LD
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
England
United Kingdom

Website	http://www.ucl.ac.uk/jro/index
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/01/2025: Internal review.
01/12/2016: No publications found in PubMed, verifying study status with principal investigator.