Xerostomia in Patients With a Life-limiting Condition or Frailty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Xerostomia Dry Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Group Type EXPERIMENTAL

Pilocarpine

Intervention Type DRUG

study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Interventions

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Pilocarpine

study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Intervention Type DRUG

Placebo

study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No