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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline.
A patient counts as a responder with, at least, a 2-point reduction on the 11-point NRS
Time frame: 4 weeks
Mean difference in NRS dry mouth scores in the pilocarpine group at all time-points, as compared to the placebo group
Mean difference in NRS dry mouth scores is determined as mean change from baseline
Time frame: 4 - 12 weeks
Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group
The OHRQoL is measured using the Geriatric Oral Health Assessment Index (GOHAI-NL)
Time frame: 4 - 12 weeks
Change in the Health-Related Quality of Life upon pilocarpine treatment, as compared to the placebo group
The HRQoL will be assessed using the EQ-5D-5L questionnaire
Time frame: 4 - 12 weeks
Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group
Clinical functioning is determined using the Patient-reported functional status (PRFS) questionnaire
Time frame: 4 - 12 weeks
Change in the Global Perceived Effect (GPE) upon pilocarpine treatment, as compared to the placebo group
The GPE is determined by a globally experienced effect score
Time frame: 4 - 12 weeks
The durability of the effect of the use of pilocarpine on xerostomia
The durability will be displayed in percentage
Time frame: 4 - 12 weeks
The adherence rate of patients
Adherence will be displayed in percentage
Time frame: 4 -12 weeks
Possible side effects related to the intake of pilocarpine medication, as compared to the placebo group
Side effects are made transparent by providing an overview of which and how many side effects occur
Time frame: 4 - 12 weeks
Cost Effectiveness Analysis (CEA) of the pilocarpine treatment
The costst of patients is analysed using the medical consumption questionnaire (iMCQ)
Time frame: 4 - 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.