ProSec 3

• Research type

  Research Study

• Full title

  A multi-centre evaluation of excessive saliva management in patients with motor neurone disease.

• IRAS ID

  238243

• Contact name

  Christopher J McDermott

• Contact email

  c.j.mcdermott@sheffield.ac.uk

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Duration of Study in the UK

  2 years, 1 months, 30 days

• 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 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:

  1.Describe how common problems with saliva are in people with MND
  2.Describe how saliva problems are currently treated
  3.Identify which and how often drugs for saliva problems cause side effects
  4.Identify the effectiveness of each treatment for saliva problems
  5.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.

  Summary of Results:
  ProSec3 was a large study, of 480 people, that sought to survey current practice in the treatment of saliva problems in people living with motor neuron disease (plwMND). We tracked disease progress of plwMND for up to 18 months, monitoring any saliva problems they developed. Almost 6 in 10 study participants reported some issues with saliva when they joined the study. We recorded any drugs they were prescribed for saliva issues, along with any side effects they caused. Additionally, a series of questions that can be scored to estimate the severity of saliva problems were asked at 3-monthly intervals. This special questionnaire, known as the ‘clinical saliva score for MND’ (CSS-MND), has proven in our study to be a good method of estimating how serious a person’s saliva problems are. The CSS-MND provides researchers with an invaluable tool that can be used to assess how good a drug is at relieving saliva problems in plwMND. As such, it will enable the testing of new drugs, with the hope of reducing issues with excess saliva and improving patient quality of life.

  Our study also attempted to answer an important question about a different questionnaire called the ALSFRS-R (the revised ALS functional rating scale), which is commonly used to assess drugs aiming to slow the overall progression of MND. Sometimes, a new treatment may lead to people living with MND who take it scoring slightly better on the ALSFRS-R than patients who are not taking the drug. However, how important and meaningful these small changes are to people living with MND is unknown. This makes it difficult for patients to make informed decisions about whether to take a particular medicine or not, especially if there are side effects. We analysed data collected as part of this study to estimate what a meaningful change in ALSFRS-R score is, namely the smallest change in score that translates to a change in functional ability that a person living with MND can actually perceive.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  18/SC/0031

• Date of REC Opinion

  9 Jan 2018

• REC opinion

  Favourable Opinion