ProSec Study

Study titleA multi-centre evaluation of excessive saliva management in patients with motor neurone disease (ProSec 3)
UK Chief InvestigatorProfessor Chris McDermott
Research summaryMotor neuron disease (MND) is a life-shortening disorder, in which the nerves needed to activate muscles die. This leads to progressive weakness of the muscles, including those needed for movement of the limbs, chewing, swallowing, and breathing. MND usually leads to death within 2-3 years. There is no cure and treatment is aimed at easing symptoms. Unfortunately, there is a lack of high quality evidence to guide doctors in the treatment of the distressing symptoms of MND. A particularly troublesome and common disease symptom is persistent drooling. Drooling causes breakdown of the skin around the mouth, speech disturbance, disruption of sleep, coughing and a higher risk of choking. Drooling of saliva can also affect a patient’s mental wellbeing, by causing distress, embarrassment and social withdrawal. Another problem is that uncontrolled drooling can prevent individuals from receiving machine-based breathing treatments, the use of which can prolong a good quality of life.

We plan to recruit 500 MND patients from around the UK, recording details of the prevalence and daily impact of saliva problems, treatments received, any side effects experienced and changes in the symptom over time. These data will enable us to:

Describe how common problems with saliva are in people with MND
Describe how saliva problems are currently treated
Identify which and how often drugs for saliva problems cause side effects
Identify the effectiveness of each treatment for saliva problems
Further develop an existing assessment tool for the severity of saliva problems in MND patients

The findings of this research will help doctors to better manage problems with excessive saliva production in people with MND and improve the quality of life of those patients. It will also verify a system of assessing the severity and progression of saliva problems, enabling the evaluation of potential treatments in future studies.
Inclusion/exclusion criteriaInclusion criteria:
- Age 18 or older
- Amyotrophic lateral sclerosis/ Primary lateral sclerosis/ Progressive muscular atrophy/ Progressive bulbar palsy as diagnosed by a consultant neurologist.

Exclusion criteria:
- Inability to give informed consent.
Current statusActive – recruiting
LocationsRoyal Hallamshire Hospital, Sheffield
Royal Preston Hospital
Salford Royal NHS Foundation Trust
University Hospitals Plymouth NHS Trust
Ninewells Hospital, Dundee; NHS Tayside
Royal Edinburgh Infirmary
The Walton Centre NHS Foundation Trust
King's College Hospital, London
Cambridge University Hospitals NHS Foundation Trust
West Suffolk Hospital NHS Trust
St George's Hospital, London
John Radcliffe Hospital, Oxford
Kent & Canterbury Hospital
Others sites being added shortly - watch this space!
Contact detailsCoordinating centre:
Dr Sarah Boddy Email: s.l.boddy@sheffield.ac.uk Phone: 0114 222 2267.
Recruitment group(s)Patients with MND.
Recruitment target(s)500 patients nationally.
Key datesRecruitment start date (actual): 20 February 2018
Recruitment end date (target): 30 November 2019
Follow-up end date (target): 30 April 2020.
Funder(s)Marie Curie and the Motor Neurone Disease Association

SponsorSheffield Teaching Hospitals NHS Foundation Trust.
Study designLongitudinal, Observational (questionnaire).
Intervention (if applicable)Not applicable.
Phase (if applicable)Not applicable.
Outcome measuresPrimary outcome measure: Frequency of secretion problems as recorded from the saliva section of the ALSFRS-R.
Secondary outcome measures: Descriptive; CSS-MND; Global change questionnaire; Modified Likert Scale.
Publications / Results reportsLinks will be provided when papers from this study are published.

Publications from the previous single-centre study (PDFs):
Management of sialorrhoea in motor neuron disease A survey of current UK practice
Management of oral secretions in neurological disease
Developing an outcome measure for excessive saliva management in MND and an evaluation of saliva burden in Sheffield
A multicentre evaluation of oropharyngeal secretion management practices in amyotrophic lateral sclerosis
Participant Information SheetDownload here