NCT06491784

Brief 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. 1.Is it feasible to recruit patients to a randomised clinical trial of exercise therapy
  2. 2.What are the barriers to study recruitment
  3. 3.What are the barriers to study retention
  4. 4.Standard of care, where the participant will undergo their usual clinical follow-up
  5. 5.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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

March 27, 2024

Last Update Submit

July 3, 2024

Conditions

Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Number of patients recruited

    Number of patients recruited to the study

    12 months

Secondary Outcomes (5)

  • Proportion of screened patients who are ineligible

    12 months

  • Study drop-out rate

    12 months

  • Intervention adherence rate

    12 months

  • Health-related Quality of Life questionnaire completion rate

    18 months

  • Framework analysis from qualitative interviews

    12 months

Study Arms (2)

Standard Care

NO INTERVENTION

Routine clinical follow-up

Exercise Therapy (Intervention)

ACTIVE COMPARATOR

12 week multi-modal exercise and wellbeing programme

Other: Exercise Therapy

Interventions

Exercise TherapyOTHER

12 week personalised exercise, nutrition and wellbeing programme

Exercise Therapy (Intervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

RECRUITING

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

RECRUITING

Related Publications (14)

  • 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.

    PMID: 15284270BACKGROUND

  • 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.

    PMID: 29587685BACKGROUND

  • 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.

    PMID: 32791881BACKGROUND

  • 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.

    PMID: 25756395BACKGROUND

  • 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.

    PMID: 33485464BACKGROUND

  • 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.

    PMID: 34429375BACKGROUND

  • 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.

    PMID: 29433474BACKGROUND

  • 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.

    PMID: 34513704BACKGROUND

  • 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.

    PMID: 30886321BACKGROUND

  • 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.

    PMID: 35328423BACKGROUND

  • 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.

    PMID: 26719503BACKGROUND

  • 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.

    PMID: 22895961BACKGROUND

  • 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.

    PMID: 35840361BACKGROUND

  • 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.

    PMID: 35413526BACKGROUND

MeSH Terms

Conditions

Mesothelioma

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Selina Tsim, PhD

    NHS Greater Glasgow & Clyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Selina Tsim, PhD

CONTACT

0141 451 6163Selina.Tsim@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open label, no masking
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 1:1 randomisation, feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

July 9, 2024

Study Start

January 25, 2024

Primary Completion

January 31, 2025

Study Completion

July 31, 2025

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)