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MesotheliomaNCT06491784

EXTRA-Meso (EXercise TheRApy in Mesothelioma) Feasibility

A study testing Exercise Therapy in people with Mesothelioma, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to learn whether running an exercise study in patients with mesothelioma is feasible. The main question(s) it aims to answer are: 1. Is it feasible to recruit patients to a randomised clinical trial of exercise therapy 2. What are the barriers to study recruitment 3. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma
What is being tested?
Exercise Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited Kingdom
Study dates
25 Jan 2024to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of mesothelioma, ratified by a mesothelioma multi-disciplinary team (MDT) meeting
  • Performance status 0 - 2
  • Clinical frailty score ≤5
  • Informed written consent

Who cannot join

  • Performance status ≥3
  • Clinical frailty score ≥6
  • Unlikely to be able to participate in an exercise programme (clinician/physiotherapist judgement)

Trial locations and contacts

2 sites in 1 country.

Selina Tsim, PhD contact

0141 451 6163

Selina.Tsim@glasgow.ac.uk

United Kingdom2 sites, 2 recruiting

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

    Selina Tsim, PhD, 0141 451 6163, Selina.Tsim@ggc.scot.nhs.uk

    Selina Tsim, PhD

    Recruiting

  • Wythenshawe Hospital

    Manchester, M23 9LT

    Matthew Evison, MD, 0161 915 320, Matthew.Evison@mft.nhs.uk

    Matthew Evison, MD

    Recruiting

Other trials in United Kingdom

About this study

Official title: EXercise TheRApy in Mesothelioma - A Feasibility Study

The goal of this clinical trial is to learn whether running an exercise study in patients with mesothelioma is feasible. The main question(s) it aims to answer are:

  1. Is it feasible to recruit patients to a randomised clinical trial of exercise therapy
  2. What are the barriers to study recruitment
  3. What are the barriers to study retention
Read more

Participants who decide to take part in the study will be randomly allocated one of two study arms:

  1. Standard of care, where the participant will undergo their usual clinical follow-up
  2. Exercise therapy, where the participant will receive a personalised 12 week exercise, nutrition and wellbeing programme Participants in both study arms will be asked to complete quality of life questionnaires and a basic fitness assessment at the start and end of the study follow-up period.

Participants will be asked if they would be happy to conduct a short interview with a member of the research team, to assess their views on the study. This interview will be audio recorded and the audio recording will be transcribed anonymously to allow researchers to improve future study design.

Read the detailed description

The aim of this study is to examine the feasibility of a randomised trial of exercise therapy in Mesothelioma. It will define likely rate of recruitment based on performance in two mesothelioma centres and identify barriers to recruitment and retention. Outcomes from the study will help refine the design of a future definitive phase 3 trial. That future phase 3 trial will have a patient-centred primary endpoint, e.g. a meaningful improvement in Health Related Quality of Life (HRQOL) or an increase in treatment uptake or tolerance. Additional outcome measures are likely to include functional fitness, hospital admissions and overall survival.

A randomised prospective feasibility study will be performed over 12 months in two centres in the United Kingdom (Glasgow and Manchester). If eligible for the study, patients will be randomised 1:1 to receive a personalised exercise programme or standard care. Patients randomised to the intervention (exercise) arm will undergo an individualised assessment by either a physiotherapist or a qualified exercise specialist with specialised exercise and health condition qualifications. Following this initial assessment, patients will receive a tailored exercise, wellbeing and nutritional support package. The investigators will assess functional fitness and health-related quality of life scores as study outcome measures. The investigators also aim to conduct semi-structured interviews in patients who decline to participate or drop out of the study in order to examine barriers to study recruitment and retention.

Conditions
Mesothelioma
Being tested
Exercise Therapy
Medical subject headings
Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise TherapyOther

    12 week personalised exercise, nutrition and wellbeing programme

Study groups in NCT06491784
Study groupRoleWhat they receive
Standard CareNo interventionRoutine clinical follow-up
Exercise Therapy (Intervention)Active comparator12 week multi-modal exercise and wellbeing programme
Receives: Other: Exercise Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients recruited

    Number of patients recruited to the study

    Measured: 12 months

Secondary outcomes (5)

  1. Proportion of screened patients who are ineligible

    Proportion of screened patients who are ineligible for the study

    Measured: 12 months

  2. Study drop-out rate

    Proportion of patients who enter the study who withdraw prior to study completion

    Measured: 12 months

  3. Intervention adherence rate

    Proportion of patients randomised to the intervention arm who complete the exercise programme

    Measured: 12 months

  4. Health-related Quality of Life questionnaire completion rate

    Number of Health-related Quality of Life questionnaires completed by participants in the study (higher numbers of completed questionnaires equates to better outcome)

    Measured: 18 months

  5. Framework analysis from qualitative interviews

    Framework analysis from qualitative interviews with study participants

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start25 Jan 2024
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomisation, feasibility study
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491784
Sponsor's protocol ID
GN22ON168
Status last verified
Jul 2024
First submitted
27 Mar 2024
Last updated
9 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nowak AK, Stockler MR, Byrne MJ. Assessing quality of life during chemotherapy for pleural mesothelioma: feasibility, validity, and results of using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and Lung Cancer Module. J Clin Oncol. 2004 Aug 1;22(15):3172-80. doi: 10.1200/JCO.2004.09.147.

    PubMed 15284270

  • Nagamatsu Y, Oze I, Aoe K, Hotta K, Kato K, Nakagawa J, Hara K, Kishimoto T, Fujimoto N. Quality of life of survivors of malignant pleural mesothelioma in Japan: a cross sectional study. BMC Cancer. 2018 Mar 27;18(1):350. doi: 10.1186/s12885-018-4293-x.

    PubMed 29587685

  • Hoon SN, Lawrie I, Qi C, Rahman N, Maskell N, Forbes K, Gerry S, Monterosso L, Chauhan A, Brims FJH. Symptom Burden and Unmet Needs in Malignant Pleural Mesothelioma: Exploratory Analyses From the RESPECT-Meso Study. J Palliat Care. 2021 Apr;36(2):113-120. doi: 10.1177/0825859720948975. Epub 2020 Aug 14.

    PubMed 32791881

  • Arnold DT, Hooper CE, Morley A, White P, Lyburn ID, Searle J, Darby M, Hall T, Hall D, Rahman NM, De Winton E, Clive A, Masani V, Dangoor A, Guglani S, Jankowska P, Lowndes SA, Harvey JE, Braybrooke JP, Maskell NA. The effect of chemotherapy on health-related quality of life in mesothelioma: results from the SWAMP trial. Br J Cancer. 2015 Mar 31;112(7):1183-9. doi: 10.1038/bjc.2015.77.

    PubMed 25756395

  • Baas P, Scherpereel A, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Jahan T, Antonia S, Oulkhouir Y, Bautista Y, Cornelissen R, Greillier L, Grossi F, Kowalski D, Rodriguez-Cid J, Aanur P, Oukessou A, Baudelet C, Zalcman G. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2021 Jan 30;397(10272):375-386. doi: 10.1016/S0140-6736(20)32714-8. Epub 2021 Jan 21.

    PubMed 33485464

  • Gravier FE, Smondack P, Prieur G, Medrinal C, Combret Y, Muir JF, Baste JM, Cuvelier A, Boujibar F, Bonnevie T. Effects of exercise training in people with non-small cell lung cancer before lung resection: a systematic review and meta-analysis. Thorax. 2022 May;77(5):486-496. doi: 10.1136/thoraxjnl-2021-217242. Epub 2021 Aug 24.

    PubMed 34429375

  • Olivier C, Grosbois JM, Cortot AB, Peres S, Heron C, Delourme J, Gierczynski M, Hoorelbeke A, Scherpereel A, Le Rouzic O. Real-life feasibility of home-based pulmonary rehabilitation in chemotherapy-treated patients with thoracic cancers: a pilot study. BMC Cancer. 2018 Feb 13;18(1):178. doi: 10.1186/s12885-018-4102-6.

    PubMed 29433474

  • Li S, Wang T, Tong G, Li X, You D, Cong M. Prognostic Impact of Sarcopenia on Clinical Outcomes in Malignancies Treated With Immune Checkpoint Inhibitors: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Aug 26;11:726257. doi: 10.3389/fonc.2021.726257. eCollection 2021.

    PubMed 34513704

  • Jeffery E, Lee YCG, Newton RU, Lyons-Wall P, McVeigh J, Nowak AK, Cheah HM, Nguyen B, Fitzgerald DB, Creaney J, Straker L, Peddle-McIntyre CJ. Body composition and nutritional status in malignant pleural mesothelioma: implications for activity levels and quality of life. Eur J Clin Nutr. 2019 Oct;73(10):1412-1421. doi: 10.1038/s41430-019-0418-9. Epub 2019 Mar 18.

    PubMed 30886321

  • Mangano GD, Fouani M, D'Amico D, Di Felice V, Barone R. Cancer-Related Cachexia: The Vicious Circle between Inflammatory Cytokines, Skeletal Muscle, Lipid Metabolism and the Possible Role of Physical Training. Int J Mol Sci. 2022 Mar 10;23(6):3004. doi: 10.3390/ijms23063004.

    PubMed 35328423

  • Gerritsen JK, Vincent AJ. Exercise improves quality of life in patients with cancer: a systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2016 Jul;50(13):796-803. doi: 10.1136/bjsports-2015-094787. Epub 2015 Dec 30.

    PubMed 26719503

  • Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2.

    PubMed 22895961

  • Bradley P, Merchant Z, Rowlinson-Groves K, Taylor M, Moore J, Evison M. Feasibility and outcomes of a real-world regional lung cancer prehabilitation programme in the UK. Br J Anaesth. 2023 Jan;130(1):e47-e55. doi: 10.1016/j.bja.2022.05.034. Epub 2022 Jul 13.

    PubMed 35840361

  • Koller M, Musoro JZ, Tomaszewski K, Coens C, King MT, Sprangers MAG, Groenvold M, Cocks K, Velikova G, Flechtner HH, Bottomley A. Minimally important differences of EORTC QLQ-C30 scales in patients with lung cancer or malignant pleural mesothelioma - Interpretation guidance derived from two randomized EORTC trials. Lung Cancer. 2022 May;167:65-72. doi: 10.1016/j.lungcan.2022.03.018. Epub 2022 Mar 29.

    PubMed 35413526

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Therapy in people with Mesothelioma, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Selina Tsim, PhD (0141 451 6163, Selina.Tsim@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients recruited (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06491784, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024; AzTrials last refreshed its copy on 5 Nov 2026.

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