Hypotheses:1. RTX to the salivary glands is a safe and effective treatment of sialorrhoea; 2. RTX to the submandibular glands is at least as effective as RTX to parotid glands 3. RTX to submandibular glands causes less adverse events than RTX to…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Sialorrhoea or drooling causes physical and emotional problems, impairing the
quality of life. Approximately 80% of patients with Parkinson*s disease suffer
from sialorrhoea due to swallowing dysfunction. Current therapies are
complicated by adverse events, limited duration of effect or invasiveness. In a
follow-up study, radiotherapy (RTX) to parotid glands was shown to be an
effective, safe long-term treatment for parkinsonism patients. However,
increased viscosity of saliva was an inconvenient complication in several
patients. Both from a theoretical (submandibular saliva is the main source of
resting saliva) and clinical view (submandibular saliva is viscous, parotid
saliva is watery), RTX to submandibular glands instead of parotid glands may
reduce this complication and may show to be more effective in treating
drooling. Unfortunately, no placebo-controlled studies on the efficacy and
safety of RTX to the salivary glands for this humiliating problem in patients
with parkinsonism are yet available in the literature.
Study objective
Hypotheses:
1. RTX to the salivary glands is a safe and effective treatment of sialorrhoea;
2. RTX to the submandibular glands is at least as effective as RTX to parotid
glands
3. RTX to submandibular glands causes less adverse events than RTX to parotid
glands
Study design
A prospective, double-blind, randomised, placebo-controlled trial, will be
performed in 45 patients with parkinsonism suffering from severe sialorrhoea.
Patients will be divided into 3 equally sized groups treated by, respectively,
placebo-RTX (1), RTX to both parotid glands (2) and RTX (3) to both
submandibular glands. Severity of sialorrhoea will be evaluated at 1, 3, 6 and
12 months post-treatment, using subjective and objective outcome measures.
Inter- and intra-group efficacy of the various treatments and adverse events of
therapy will be analysed.
The placebo-group will receive radiotherapy after 6 months and they will also
be evaluated at 6 months post-treatment.
Intervention
Radiotherapy to the parotid, submandibular glands or placebo-radiotherapy.
Study burden and risks
In a follow-up study, radiotherapy (RTX) to parotid glands was shown to be an
effective, safe long-term treatment for parkinsonism patients.
Also 3 studies report about the role of RTX for sialorrhoea in patients with
neurodegenerative disorders and describe good results concerning efficacy and
safety.
The risk of inducing secondary malignancy by radiotherapy is less than 1% and
since most patients are in advances stage of disease with limited life
expectancy.
This study tries to establish the efficiacy and safety of RTX as an important
treatment of sialorrhoea. therfore the field of movement disorders will
hopefully benefit from the results of this research.
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
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 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30440.042.10 |