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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
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    October 12, 2016
    Last Updated
    October 29, 2021
    Sponsor
    University College, London
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    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

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