Xerostomia in Patients With a Life-limiting Condition or Frailty
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Marieke van den Beuken- van Everdingen, Prof.; Evelien Neis, Dr.
Data sourced from clinicaltrials.gov
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