hull-mba-jaishree

Morphine and Breathlessness Study (MABEL)

Study Design:

CTIMP RCT

Disease Area:

Respiratory / Palliative Care

Funder:

NIHR HTA

Chief Investigator:

Professor Miriam Johnson, Wolfson Palliative Care Research Centre, Hull and York Medical School, University of Hull

Contact:

kathryn.date@hyms.ac.uk

mabel-logo

Summary

Chronic breathlessness affects most people with advanced lung cancer, lung fibrosis, COPD (chronic obstructive pulmonary disease; emphysema) and heart failure. People are often disabled by this long-term breathlessness despite best treatments of the underlying condition(s). Chronic breathlessness is frightening for patients and their families. It reduces quality of life, limits how people manage at home with everyday functions (bathing, dressing, preparing food) and at work, increases the number of emergency hospital visits and admissions, and shortens life (although some people may live with chronic breathlessness for many years). Studies of a few days of regular, low doses of ”long-acting” morphine show that this can help reduce chronic breathlessness safely, particularly for people with COPD - but we don't know if it keeps working when used for longer periods, or if it does any harm in the longer term. At present, some doctors will prescribe morphine for breathlessness and others won’t.

What we plan to do

We will test if regular, low dose morphine capsules regularly twice a day are better than placebo (dummy) ones for chronic breathlessness and whether morphine improves daily activity in 158 people. We will also see any effect on the need to go to Accident & Emergency, call an ambulance, phone a GP after hours, or go into hospital. We will cost this care and, if it works, find the best ways to provide long-acting morphine to people who need it and would safely benefit from it.

People with fully treated disease still causing chronic breathlessness participating in the study will be chosen at random to have either morphine or a placebo capsule twice a day for two months. After a week, the dose will be increased if breathlessness isn’t improving and they don’t want to stop because of side-effects. At the end, participants can try morphine as part of their usual care if they want from their GP or usual hospital doctor, while being followed up by the study team. We will judge success on how participants’ worst daily breathlessness feels.  We will also measure how much activity they actually do (daily step count), quality of life, how well the person sleeps, possible side-effects, overall ability to function, use of healthcare services and - as the study includes people with serious illness - survival. Family members will also be able to help by completing questionnaires telling us about caring for someone with breathlessness. Alongside the study, we will ask clinicians and study participants about issues which would help or hinder patients to have routine access to regular, low dose morphine for breathlessness if the study shows it is the better treatment.

What will we achieve

If the study shows that morphine helps, and doesn’t harm, we want all suitable patients to be able to have access to it. However, we know some doctors, nurses, patients and carers may have concerns about morphine, so we will find out what support is needed to make sure morphine is available, and used carefully and in accordance with the evidence.

If you are a patient or a member of the public with experience in this area and would be interested in joining a group to help shape the ongoing development of the database and how we handle this data, please contact Dr Kathryn Date (01482 464770) who would be happy to discuss this with you. 

Trial progress

In set-up
 
 
 
 

Contact

Hull Health Trials Unit
3rd Floor AMB
University of Hull
Hull
HU6 7RX
UK