Overview

Xerostomia in Patients With a Life-limiting Condition or Frailty

Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Maastricht University Medical Center
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Treatments:
Pilocarpine
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