Drooling Sialorrhoea
Conditions
Interventions
Radiotherapy to the parotid, submandibular glands or placebo-radiotherapy.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria are: 1. Clinical symptoms of parkinsonism 2. A diagnosis of severe sialorrhoea (score 3 or 4 on item 6 of the Activities of Daily Living (ADL) section of the Unified Parkinson*s Disease Rating Scale (UPDRS)) 3. Written informed consent obtained from the patient 4. All patients must be older than 50 years of age
Exclusion criteria
Exclusion criteria: Exclusion criteria are: 1. Concurrent participation in another investigational study. 2. The use of drugs, like anticholinergic drugs, that interfere with saliva secretion. 3. Previous surgical procedures in the oral or nasal cavity interfering with saliva production. 4. A history of (pre)malignancy in the radiation treatment portal. 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The score on item 6 of the ADL-section of the Unified Parkinson*s Disease Rating Scale (UPDRS) will be used as primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical global impression scale (CGI), the semi-quantitative Drooling Quotient (DQ) and the *swab method* will serve as secondary endpoints, as well as a structured adverse event questionnaire. | — |
Countries
Netherlands
Outcome results
None listed