ProSec 3 study

A multicentre evaluation of excessive saliva management in patients with motor neurone disease (ProSec 3)

UK Chief Investigator

Professor Chris McDermott

Research summary

Motor 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 two to three 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 criteria

Inclusion criteria

• Aged 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 status

Study completed - topline results presented.

Locations

England:

• Birmingham

• Bradford

• Bury St Edmunds

• Cambridge

• Canterbury

• Coventry

• Farnham, Surrey

• Leeds

• Leicester

• Liverpool

• London (King's College Hospital)

• London (Royal London Hospital)

• London (St George's Hospital, Tooting)

• Luton

• Manchester

• Newcastle

• Oxford

• Plymouth

• Preston

• Rochester

• Salford

• Sheffield

• Solihull

• Somerset Partnership Community Care

• Stoke

• Sussex Community NHS Foundation Trust

Scotland:

• Ayrshire

• Dundee

• Edinburgh

• Glasgow

Wales:

• Llanelli

Information about study sites

Contact details

Coordinating centre: Dr Sarah Boddy

Email: s.l.boddy@sheffield.ac.uk

Telephone: +44 114 222 2267

Recruitment groups

Patients with MND

Recruitment target

500 patients nationally

Key dates

Recruitment start date (actual): 20 February 2018

Recruitment end date (actual): 30 August 2020

Follow-up end date: 30 August 2020

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Study design

Longitudinal, observational (questionnaire)

Outcome measures

Primary 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 reports

Links will be provided when papers from this study are published.

Publications from the previous single-centre study:

• Management of sialorrhoea in motor neuron disease: A survey of current UK practice (PDF, 393KB)

• Management of oral secretions in neurological disease (PDF, 2.5MB)

• Developing an outcome measure for excessive saliva management in MND and an evaluation of saliva burden in Sheffield (PDF, 399KB)

• A multicentre evaluation of oropharyngeal secretion management practices in amyotrophic lateral sclerosis (PDF, 760KB)