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A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer (LEONIDAS-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02941276
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE October 12, 2016
First Posted Date  ICMJE October 21, 2016
Last Update Posted Date May 18, 2017
Study Start Date  ICMJE November 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2016)
Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale [ Time Frame: 12 month ]
The primary outcome is defined as the proportion of patients reporting a 30% reduction of xerostomia symptoms as evaluated through a 100mm VAS (100mm=maximum dryness).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2016)
  • Improvement of objective salivary function as measured through 5-minutes sialometry [ Time Frame: 12 month ]
  • Improvement in head and neck quality of life as measured on the EORTC QLQ-H&N35 [ Time Frame: 12 month ]
  • Improvement in oral health quality of life as measured on the OH-QoL16 questionnaire [ Time Frame: 12 month ]
  • Improvement in general quality of life as measured on the SF-36 questionnaire [ Time Frame: 12 month ]
  • Evaluation of patients' tolerance in using the device by using a diary to record daily measurement. [ Time Frame: 12 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer
Official Title  ICMJE Long-term Evaluation of the Effectiveness Of a Novel Intra-oral Electro-stimulator for the Treatment of raDiotherapy-ASsociated Dry Mouth
Brief Summary This trial is looking at using an intra-oral electrostimulating device for the management of radiotherapy-induced dry mouth.
Detailed Description Dry mouth is a common complaint of radiotherapy for cancer of the head and neck region. It is a distressing often persistent condition which can lead to longlasting oral discomfort, dental infections, diminished quality of life, social isolation and loneliness. Unfortunately, current therapies of dry mouth are often unsatisfactory, expensive and may result in adverse effects. A novel intraoral electronic device has recently been developed to treat dry mouth. The device, acting as a "salivary pacemaker", harmlessly stimulates nerves of the salivary glands and does not cause adverse side effects. The aim of this proposal is to assess the longterm effects of such a device in this population, which have yet to be investigated, to demonstrate whether its daily application is an effective method of lessening dry mouth and improving life quality. 84 individuals will be enrolled in the study to use the device for 12 months, after receiving appropriate instructions. 42 participants (out of 84) will act as controls as they will receive a sham device that will not deliver electric stimuli but only tactile stimulation (like using a chewing gum). All participants will be allowed to continue using their routine local therapy for dry mouth (e.g. artificial saliva) during the study. Each participant will keep a diary relevant to the frequency of use and potential changes in dry mouth sensation. Participants will also be asked to attend hospital appointments to measure changes in saliva production and complete questionnaires on their dry mouth and quality of life. The device has the potential to radically change current clinical practice. If the trial is successful, the use of the device will provide patients having radiation-induced dry mouth with a safe and drug-free therapeutic modality.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Xerostomia
  • Head and Neck Neoplasms
Intervention  ICMJE
  • Device: Active Electrostimulator device
    Patients who will receive a fully functioning device
  • Device: Sham Electrostimulator device
    Patients who will receive a device that does not release electric stimuli (but provided mechanical/tactile stimulation)
Study Arms  ICMJE
  • Experimental: Group A
    Active electrostimulator device
    Intervention: Device: Active Electrostimulator device
  • Sham Comparator: Group B
    Sham electrostimulator device
    Intervention: Device: Sham Electrostimulator device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2016)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. To be at least 18 years old
  2. To have received more than 40 Gy of external beam RT for cancer in the H&N region at least 4 months before entry into the study
  3. To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema
  4. To have a degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm 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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02941276
Other Study ID Numbers  ICMJE 11/YH/0072
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Research manuscript in preparation.
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Stefano Fedele, PhD University College, London
PRS Account University College, London
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP