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Xerostomia in Patients With a Life-limiting Condition or Frailty

Primary Purpose

Xerostomia, Dry Mouth

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pilocarpine
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, Dry mouth, Pilocarpine

Eligibility Criteria

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

Inclusion Criteria:

  • have a life-limiting condition or frailty
  • have the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0= no dry mouth to 10= worst dry mouth ever)
  • fulfil the single SQ 'Would I be surprised if my patient dies within the year? (no)

Exclusion Criteria:

  • their life expectancy is less than 4 weeks (the primary endpoint at 4 weeks)
  • they have had radiotherapy to the salivary glands or suffer from Sjögrens disease (impact on dry mouth)
  • cognitively impaired to such an extent that there is insufficient understanding to complete questionnaires

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treatment

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline.
    A patient counts as a responder with, at least, a 2-point reduction on the 11-point NRS

    Secondary Outcome Measures

    Mean difference in NRS dry mouth scores in the pilocarpine group at all time-points, as compared to the placebo group
    Mean difference in NRS dry mouth scores is determined as mean change from baseline
    Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group
    The OHRQoL is measured using the Geriatric Oral Health Assessment Index (GOHAI-NL)
    Change in the Health-Related Quality of Life upon pilocarpine treatment, as compared to the placebo group
    The HRQoL will be assessed using the EQ-5D-5L questionnaire
    Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group
    Clinical functioning is determined using the Patient-reported functional status (PRFS) questionnaire
    Change in the Global Perceived Effect (GPE) upon pilocarpine treatment, as compared to the placebo group
    The GPE is determined by a globally experienced effect score
    The durability of the effect of the use of pilocarpine on xerostomia
    The durability will be displayed in percentage
    The adherence rate of patients
    Adherence will be displayed in percentage
    Possible side effects related to the intake of pilocarpine medication, as compared to the placebo group
    Side effects are made transparent by providing an overview of which and how many side effects occur
    Cost Effectiveness Analysis (CEA) of the pilocarpine treatment
    The costst of patients is analysed using the medical consumption questionnaire (iMCQ)

    Full Information

    First Posted
    August 16, 2022
    Last Updated
    August 16, 2022
    Sponsor
    Maastricht University Medical Center
    Collaborators
    ZonMw: The Netherlands Organisation for Health Research and Development
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05506137
    Brief Title
    Xerostomia in Patients With a Life-limiting Condition or Frailty
    Official Title
    Xerostomia in Patients With a Life-limiting Condition or Frailty: a Double-blind Placebo-controlled Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maastricht University Medical Center
    Collaborators
    ZonMw: The Netherlands Organisation for Health Research and Development

    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
    Xerostomia, the subjective feeling of dry mouth, is a common symptom during the last year of life in patients with a life-limiting condition or frailty. Xerostomia leads to functional alterations (such as burning sensations, an altered taste perception, and difficulties with chewing, swallowing, and speaking), has disabling social consequences and significantly downgrades the perceived quality of life. It is an under-exposed and under-treated symptom often caused by alterations in the quality and quantity of saliva. Locally administered pilocarpine could be a promising drug in this regard as it alleviates xerostomia by increasing the production of saliva.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Xerostomia, Dry Mouth
    Keywords
    Xerostomia, Dry mouth, Pilocarpine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Pilocarpine
    Intervention Description
    study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
    Primary Outcome Measure Information:
    Title
    The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline.
    Description
    A patient counts as a responder with, at least, a 2-point reduction on the 11-point NRS
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Mean difference in NRS dry mouth scores in the pilocarpine group at all time-points, as compared to the placebo group
    Description
    Mean difference in NRS dry mouth scores is determined as mean change from baseline
    Time Frame
    4 - 12 weeks
    Title
    Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group
    Description
    The OHRQoL is measured using the Geriatric Oral Health Assessment Index (GOHAI-NL)
    Time Frame
    4 - 12 weeks
    Title
    Change in the Health-Related Quality of Life upon pilocarpine treatment, as compared to the placebo group
    Description
    The HRQoL will be assessed using the EQ-5D-5L questionnaire
    Time Frame
    4 - 12 weeks
    Title
    Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group
    Description
    Clinical functioning is determined using the Patient-reported functional status (PRFS) questionnaire
    Time Frame
    4 - 12 weeks
    Title
    Change in the Global Perceived Effect (GPE) upon pilocarpine treatment, as compared to the placebo group
    Description
    The GPE is determined by a globally experienced effect score
    Time Frame
    4 - 12 weeks
    Title
    The durability of the effect of the use of pilocarpine on xerostomia
    Description
    The durability will be displayed in percentage
    Time Frame
    4 - 12 weeks
    Title
    The adherence rate of patients
    Description
    Adherence will be displayed in percentage
    Time Frame
    4 -12 weeks
    Title
    Possible side effects related to the intake of pilocarpine medication, as compared to the placebo group
    Description
    Side effects are made transparent by providing an overview of which and how many side effects occur
    Time Frame
    4 - 12 weeks
    Title
    Cost Effectiveness Analysis (CEA) of the pilocarpine treatment
    Description
    The costst of patients is analysed using the medical consumption questionnaire (iMCQ)
    Time Frame
    4 - 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: have a life-limiting condition or frailty have the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0= no dry mouth to 10= worst dry mouth ever) fulfil the single SQ 'Would I be surprised if my patient dies within the year? (no) Exclusion Criteria: their life expectancy is less than 4 weeks (the primary endpoint at 4 weeks) they have had radiotherapy to the salivary glands or suffer from Sjögrens disease (impact on dry mouth) cognitively impaired to such an extent that there is insufficient understanding to complete questionnaires
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marieke van den Beuken- van Everdingen, Prof.
    Phone
    0031(0)43 3877392
    Email
    m.vanden.beuken@mumc.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Evelien Neis, Dr.
    Phone
    0031(0)43 3875610
    Email
    evelien.neis@mumc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marieke van den Beuken- van Everdingen, Prof.
    Organizational Affiliation
    Maastricht University and/or Maastricht UMC+
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32800514
    Citation
    Theunissen M, Rideaux-Seferina S, Magdelijns FJ, Janssen DJA, van den Beuken-van Everdingen MHJ. Local Oral Pilocarpine Drops for Relieving Xerostomia (Dry Mouth) in the Elderly: A Pilot Study. J Am Med Dir Assoc. 2021 Jan;22(1):185-186. doi: 10.1016/j.jamda.2020.06.036. Epub 2020 Aug 13. No abstract available.
    Results Reference
    background
    Links:
    URL
    https://www.zonmw.nl/nl/over-zonmw/onderwijs/programmas/project-detail/palliantie-meer-dan-zorg/dry-mouth-in-patients-with-a-life-limiting-condition-or-frailty-a-two-track-non-pharmacological-and/
    Description
    ZonMW Programma Palliantie

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    Xerostomia in Patients With a Life-limiting Condition or Frailty

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