Clinical trial NCT05506137: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Xerostomia
Dry Mouth
Keywords: Xerostomia
Dry mouth
Pilocarpine
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-08-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline.
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean difference in NRS dry mouth scores in the pilocarpine group at all time-points, as compared to the placebo group
timeFrame: 4 - 12 weeks
measure: Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group
timeFrame: 4 - 12 weeks
measure: Change in the Health-Related Quality of Life upon pilocarpine treatment, as compared to the placebo group
timeFrame: 4 - 12 weeks
measure: Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group
timeFrame: 4 - 12 weeks
measure: Change in the Global Perceived Effect (GPE) upon pilocarpine treatment, as compared to the placebo group
timeFrame: 4 - 12 weeks
measure: The durability of the effect of the use of pilocarpine on xerostomia
timeFrame: 4 - 12 weeks
measure: The adherence rate of patients
timeFrame: 4 -12 weeks
measure: Possible side effects related to the intake of pilocarpine medication, as compared to the placebo group
timeFrame: 4 - 12 weeks
measure: Cost Effectiveness Analysis (CEA) of the pilocarpine treatment
timeFrame: 4 - 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Maastricht University and/or Maastricht UMC+
name: Marieke van den Beuken- van Everdingen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.