Xerostomia in Patients With a Life-limiting Condition or Frailty

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05506137

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia Dry Mouth	Drug: Pilocarpine Other: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment	Drug: Pilocarpine study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
Placebo Comparator: Placebo	Other: Placebo study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Arm

Intervention/Treatment

Experimental: Treatment

Drug: Pilocarpine

study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Placebo Comparator: Placebo

Other: Placebo

study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Outcome Measures

Primary Outcome Measures

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

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 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 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
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
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
The adherence rate of patients [4 -12 weeks]
Adherence will be displayed in percentage
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
Cost Effectiveness Analysis (CEA) of the pilocarpine treatment [4 - 12 weeks]
The costst of patients is analysed using the medical consumption questionnaire (iMCQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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