Xerostomia in Patients With a Life-limiting Condition or Frailty

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05506137
• Other study ID #: 2022-501084-41-00
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2023
• Est. completion date: June 2025

Study information

• Verified date: August 2022
• Source: Maastricht University Medical Center
• Contact: Marieke van den Beuken- van Everdingen, Prof.
• Phone: 0031(0)43 3877392
• Email: m.vanden.beuken[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Mouth
• Frailty
• Xerostomia

Intervention

Drug:
• Pilocarpine
study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Other:
• Placebo
study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

References & Publications (1)

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. — View Citation

Outcome

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

External Links

•   ZonMW Programma Palliantie