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 |
| Protocol serial number | 10229 |
| Sponsor | University College London Hospitals NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research |
- 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
Contact information
Dr Stefano Fedele
Scientific
Scientific
Eastman Dental Institute
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
| Phone | +44 207 915 1004 |
|---|---|
| s.fedele@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
VAS dry mouth score; Timepoint(s): Month 0 and 12 as part of follow-up appointments |
| Key secondary outcome measure(s) |
1.Home diary; Timepoint(s): To record fequency of device application and weekly VAS dry mouth score |
| Completion date | 01/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Eastman Dental Institute
London
WC1X 8LD
United Kingdom
WC1X 8LD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/01/2025: Internal review.
01/12/2016: No publications found in PubMed, verifying study status with principal investigator.
