Xerostomia in Patients With a Life-limiting Condition or Frailty

Study Overview
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Brief Summary
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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.

Official Title
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Xerostomia in Patients With a Life-limiting Condition or Frailty: a Double-blind Placebo-controlled Randomized Clinical Trial

Conditions
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Xerostomia, Dry Mouth

Intervention / Treatment
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* Drug: Pilocarpine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: Pilocarpine<br>* study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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 | 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 | 4 - 12 weeks | 
| The durability of the effect of the use of pilocarpine on xerostomia | The durability will be displayed in percentage | 4 - 12 weeks | 
| The adherence rate of patients | Adherence will be displayed in percentage | 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 | 4 - 12 weeks | 
| Cost Effectiveness Analysis (CEA) of the pilocarpine treatment | The costst of patients is analysed using the medical consumption questionnaire (iMCQ) | 4 - 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xerostomia, Dry mouth, Pilocarpine