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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilocarpine | Drug | study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marieke van den Beuken- van Everdingen, Prof. | Contact | 0031(0)43 3877392 | m.vanden.beuken@mumc.nl | |
| Evelien Neis, Dr. | Contact | 0031(0)43 3875610 | evelien.neis@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marieke van den Beuken- van Everdingen, Prof. | Maastricht University and/or Maastricht UMC+ | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32800514 | Background | Theunissen M, Rideaux-Seferina S, Magdelijns FJ, Janssen DJA, van den Beuken-van Everdingen MHJ. Local Oral Pilocarpine Drops for Relieving Xerostomia (Dry Mouth) in the Elderly: A Pilot Study. J Am Med Dir Assoc. 2021 Jan;22(1):185-186. doi: 10.1016/j.jamda.2020.06.036. Epub 2020 Aug 13. No abstract available. | |
| 37612654 | Derived |
| Label | URL |
|---|---|
| ZonMW Programma Palliantie | View source |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D010862 | Pilocarpine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other | study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia |
|
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 |
| van der Meulen AI, Neis EPJG, de Nijs EJM, Coenegracht BJEG, Stoppelenburg A, van den Beuken-van Everdingen MHJ, van der Linden YM. Dry mouth in patients with a life-limiting condition or frailty: a study protocol for two intervention studies and a nested qualitative sub-study (the Dry mOuth Project, DROP). BMC Palliat Care. 2023 Aug 23;22(1):120. doi: 10.1186/s12904-023-01242-0. |