Exercise in mesothelioma study
| ISRCTN | ISRCTN24557328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24557328 |
| IRAS number | 315059 |
| ClinicalTrials.gov number | NCT06491784 |
| Secondary identifying numbers | CPMS 58172 |
- Submission date
- 02/08/2024
- Registration date
- 22/10/2024
- Last edited
- 06/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Malignant pleural mesothelioma (MPM) is an aggressive cancer that is strongly associated with asbestos exposure. It most frequently affects the lining of the lung (pleura), but can also affect the other parts of the body, including the lining of the heart and abdomen. Patients with MPM often experience troublesome symptoms including breathlessness, pain and fatigue. They can also experience anxiety and depression and feel like their quality of life is worse than before they were diagnosed. Unfortunately, the average life expectancy following a diagnosis of mesothelioma is about 12 months. Currently, treatment in patients who are fit enough is aimed at prolonging this life expectancy and involves drug treatment in the form of either chemotherapy or more recently immunotherapy. Whether a person with mesothelioma receives this treatment can depend on their physical fitness. Improving health-related quality of life (HRQoL) and physical fitness is a key goal for all patients with MPM, and maximising treatment opportunities has never been more important following the recent approval of immunotherapy for the treatment of MPM across the UK. Exercise therapy is a rational approach to improving HRQoL and could also improve and/or maintain physical fitness to allow more patients to ultimately receive treatment. There is currently no evidence for the role of exercise therapy in mesothelioma. The aim of this study is to determine whether it is feasible to recruit and randomise patients with mesothelioma in a study of exercise therapy.
Who can participate?
Patients aged 18 years and over with mesothelioma
What does the study involve?
Once a participant consents to the study, they will undergo a baseline assessment, which will include the completion of an HRQoL questionnaire and a fitness assessment, which will include a 6-minute walk test (which measures the distance the participant can walk in 6 minutes), a hand grip strength measurement and counting how many times the participant can rise from a chair in 30 seconds (30-second sit to stand test). Once this baseline assessment has been completed, participants are randomly allocated to either intervention or standard of care. The intervention group involves the participant being assessed by a qualified physiotherapist or qualified exercise specialist with specialist cancer training before being provided with a 12-week personalised exercise and wellbeing programme, which includes exercise three times per week. Participants will be asked to complete HRQoL questionnaires at about 8, 16 and 26 weeks after enrolment; and functional fitness testing at 16 weeks after enrolment. The standard of care group involves routine clinical follow-up with completion of HRQoL questionnaires at about 8, 16 and 26 weeks after enrolment; and functional fitness testing at 16 weeks after enrolment.
What are the possible benefits and risks of participating?
It is possible that a personalised exercise programme could improve symptoms and quality of life in patients with mesothelioma. However, it is important to stress that this is not yet proven and will need testing in a larger study if the current study shows promising results.
Exercise in patients with mesothelioma is generally safe, however, exercise can be associated with complications such as joint pain, muscle soreness, injury and fatigue. Very uncommonly, exercise can be associated with heart attack or heart rhythm abnormality, but this is rare, even in people with a heart condition and extremely rare in people who do not have pre-existing heart conditions.
Where is the study run from?
The study is run from two UK mesothelioma centres: The Queen Elizabeth University Hospital in Glasgow and Wythenshawe Hospital in Manchester.
When is the study starting and how long is it expected to run for?
July 2023 to July 2025
Who is funding the study?
Mesothelioma UK
Who is the main contact?
Dr Selina Tsim, selina.tsim@glasgow.ac.uk
Contact information
Public, Scientific, Principal Investigator
Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
| Phone | +44 (0)141 451 6163 |
|---|---|
| Selina.Tsim@glasgow.ac.uk |
Study information
| Study design | Multi-centre non-blinded randomized feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other, Quality of life, Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | EXercise TheRApy in Mesothelioma - The EXTRA-Meso feasibility study |
| Study acronym | EXTRA-Meso |
| Study objectives | Study hypothesis is that it is feasible to recruit patients with mesothelioma to a randomised study of exercise therapy versus standard care |
| Ethics approval(s) |
Approved 02/10/2023, West Midlands - South Birmingham Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)207 104 8345; southbirmingham.rec@hra.nhs.uk), ref: 23/WM/0186 |
| Health condition(s) or problem(s) studied | Mesothelioma |
| Intervention | Once a participant consents to the study, they will undergo a baseline assessment, which will include the completion of an HRQoL questionnaire and a fitness assessment, which will include a 6-minute walk test (which measures the distance the participant can walk in 6 minutes), a hand grip strength measurement and counting how many times the participant can rise from a chair in 30 seconds (30-second sit to stand test). Once this baseline assessment has been completed, participants are randomly allocated to either intervention or standard of care. Randomisation is a 1:1 randomisation using random permuted blocks via a validated online system (sealedenvelope.com). The intervention group involves the participant being assessed by a qualified physiotherapist or qualified exercise specialist with specialist cancer training before being provided with a 12-week personalised exercise and wellbeing programme, which includes exercise three times per week. Participants will be asked to complete HRQoL questionnaires at about 8, 16 and 26 weeks after enrolment; and functional fitness testing at 16 weeks after enrolment. The standard of care group involves routine clinical follow-up with completion of HRQoL questionnaires at about 8, 16 and 26 weeks after enrolment; and functional fitness testing at 16 weeks after enrolment. |
| Intervention type | Other |
| Primary outcome measure | Total number of patients recruited over 12 months |
| Secondary outcome measures | 1. Proportion of screened patients who do not meet study eligibility over 12 months 2. Of the patients who fail screening, which eligibility criteria have they failed to meet, over the 12-month recruitment period 3. Study drop-out rate, described as the proportion of patients enrolled in the study who withdraw before the end of the study period 4. Reasons for study drop-out (free text) recorded over the duration of the study period (18 months) 5. Intervention adherence rate, described as the proportion of patients randomised to exercise therapy who complete the 12-week exercise programme 6. Adverse events recorded over the duration of the study period (18 months) 7. Health-related quality of life (HRQoL) questionnaire completion rate, described as the proportion of questionnaires completed by study participants over the duration of the study period (18 months) |
| Overall study start date | 01/07/2023 |
| Completion date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Diagnosis of mesothelioma, ratified by a mesothelioma multi-disciplinary team (MDT) 2. Performance status 0 - 2 3. Clinical frailty score ≤5 4. Informed consent |
| Key exclusion criteria | 1. Performance status ≥3 2. Clinical frailty score ≥6 3. Unlikely to be able to participate in an exercise programme (clinician/physiotherapist judgement) |
| Date of first enrolment | 30/01/2024 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Glasgow
G51 4TF
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation
Dykebar Hospital
Ward 11
Grahamston Road
Paisley
Glasgow
PA2 7DE
Scotland
United Kingdom
| Phone | +44 (0)141 314 4001 |
|---|---|
| Kirsty.Theron@ggc.scot.nhs.uk | |
| Website | http://www.nhsggc.org.uk/ |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Selina Tsim (selina.tsim@glasgow.ac.uk). Data (HRQOL summary, functional fitness data summary, intervention adherence and dropout rate) will become available at the completion of study follow-up and data cleaning (approximately 31/10/2025). Consent to do so will be sought from participants via the participant information sheet and study consent form. All data would be anonymised as per ethical approval. |
Editorial Notes
06/11/2024: Internal review.
02/08/2024: Study's existence confirmed by West Midlands - South Birmingham Research Ethics Committee.
