Dry Mouth, Xerostomia
Conditions
Keywords
Xerostomia, Dry mouth, Pilocarpine
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.
Interventions
DRUGPilocarpine
study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
OTHERPlacebo
study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline. | 4 weeks | A patient counts as a responder with, at least, a 2-point reduction on the 11-point NRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group | 4 - 12 weeks | 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 | 4 - 12 weeks | The HRQoL will be assessed using the EQ-5D-5L questionnaire |
| Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group | 4 - 12 weeks | 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 | 4 - 12 weeks | The GPE is determined by a globally experienced effect score |
| Mean difference in NRS dry mouth scores in the pilocarpine group at all time-points, as compared to the placebo group | 4 - 12 weeks | Mean difference in NRS dry mouth scores is determined as mean change from baseline |
| The adherence rate of patients | 4 -12 weeks | Adherence will be displayed in percentage |
| Possible side effects related to the intake of pilocarpine medication, as compared to the placebo group | 4 - 12 weeks | 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 | 4 - 12 weeks | The costst of patients is analysed using the medical consumption questionnaire (iMCQ) |
| The durability of the effect of the use of pilocarpine on xerostomia | 4 - 12 weeks | The durability will be displayed in percentage |
Contacts
Primary ContactMarieke van den Beuken- van Everdingen, Prof.
Backup ContactEvelien Neis, Dr.
Outcome results
None listed