Condition category
Digestive System
Date applied
28/10/2011
Date assigned
28/10/2011
Last edited
01/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.ucl.ac.uk/jro/index

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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