A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer (LEONIDAS-2)
Primary Purpose
Xerostomia, Head and Neck Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active Electrostimulator device
Sham Electrostimulator device
Sponsored by
About this trial
This is an interventional treatment trial for Xerostomia
Eligibility Criteria
Inclusion Criteria:
- To be at least 18 years old
- 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
- To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema
To have a degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm VAS scale (0=no dryness; 100
=maximum dryness).
- To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax)
- To have at least one parotid gland
Exclusion Criteria:
- To have severe uncontrolled systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASA IV and ASA V)
- To have known allergy to materials similar to those used in the investigational product
- To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids
- To have an unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow as measured via sialometry for 15 minutes).
- To use of pilocarpine as systemic therapy
- To have grade 3 RTOG/EROTC or no resting saliva (sialometry = 0mL/1.5 min)
- To have no parotid glands
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Group A
Group B
Arm Description
Active electrostimulator device (intra-oral active second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)
Sham electrostimulator device (intra-oral sham second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)
Outcomes
Primary Outcome Measures
Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale
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).
Secondary Outcome Measures
Salivary function
Improvement of objective salivary function as measured through 5-minutes sialometry
Head and Neck cancer Quality of Life
Improvement in head and neck quality of life as measured on the EORTC QLQ-H&N35
Oral Health Quality of Life
Improvement in oral health quality of life as measured on the OH-QoL16 questionnaire
General quality of Life
Improvement in general quality of life as measured on the SF-36 questionnaire
Participant compliance
Evaluation of patients' tolerance in using the device by using a diary to record daily measurement.
Full Information
NCT ID
NCT02941276
First Posted
October 12, 2016
Last Updated
October 29, 2021
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT02941276
Brief Title
A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer
Acronym
LEONIDAS-2
Official Title
Long-term Evaluation of the Effectiveness Of a Novel Intra-oral Electro-stimulator for the Treatment of raDiotherapy-ASsociated Dry Mouth
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Head and Neck Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Active electrostimulator device (intra-oral active second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)
Arm Title
Group B
Arm Type
Sham Comparator
Arm Description
Sham electrostimulator device (intra-oral sham second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)
Intervention Type
Device
Intervention Name(s)
Active Electrostimulator device
Intervention Description
Patients who will receive a fully functioning device
Intervention Type
Device
Intervention Name(s)
Sham Electrostimulator device
Intervention Description
Patients who will receive a device that does not release electric stimuli (but provided mechanical/tactile stimulation)
Primary Outcome Measure Information:
Title
Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale
Description
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).
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Salivary function
Description
Improvement of objective salivary function as measured through 5-minutes sialometry
Time Frame
12 month
Title
Head and Neck cancer Quality of Life
Description
Improvement in head and neck quality of life as measured on the EORTC QLQ-H&N35
Time Frame
12 month
Title
Oral Health Quality of Life
Description
Improvement in oral health quality of life as measured on the OH-QoL16 questionnaire
Time Frame
12 month
Title
General quality of Life
Description
Improvement in general quality of life as measured on the SF-36 questionnaire
Time Frame
12 month
Title
Participant compliance
Description
Evaluation of patients' tolerance in using the device by using a diary to record daily measurement.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be at least 18 years old
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
To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema
To have a degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm VAS scale (0=no dryness; 100
=maximum dryness).
To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax)
To have at least one parotid gland
Exclusion Criteria:
To have severe uncontrolled systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASA IV and ASA V)
To have known allergy to materials similar to those used in the investigational product
To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids
To have an unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow as measured via sialometry for 15 minutes).
To use of pilocarpine as systemic therapy
To have grade 3 RTOG/EROTC or no resting saliva (sialometry = 0mL/1.5 min)
To have no parotid glands
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Stefano Fedele, PhD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer
We'll reach out to this number within 24 hrs