Xerostomia in Patients With a Life-limiting Condition or Frailty
- Registration Number
- NCT05506137
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Treatment Pilocarpine -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The adherence rate of patients 4 -12 weeks Adherence will be displayed in percentage
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
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
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
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 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
The durability of the effect of the use of pilocarpine on xerostomia 4 - 12 weeks The durability will be displayed in percentage
Cost Effectiveness Analysis (CEA) of the pilocarpine treatment 4 - 12 weeks The costst of patients is analysed using the medical consumption questionnaire (iMCQ)
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