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
About this trial
This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, Dry mouth, Pilocarpine
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
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
NCT ID
NCT05506137
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
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
Learn more about this trial
Xerostomia in Patients With a Life-limiting Condition or Frailty
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