Author Identifier

Hao Luo

ORCID : 0000-0001-5181-7529

Daniel A Galvao

ORCID : 0000-0002-8209-2281

Rob Newton

ORCID : 0000-0003-0302-6129

Dennis Taaffe

ORCID : 0000-0001-6381-1597

Document Type

Journal Article

Publication Title

BMJ Open Gastroenterology

Publisher

BMJ Publishing Group

School

School of Medical and Health Sciences / Exercise Medicine Research Institute

RAS ID

35714

Funders

Edith Cowan University - Open Access Support Scheme 2021

Comments

Luo, H., Galvão, D. A., Newton, R. U., Tang, C., Dean, A., Jasas, K., . . . Taaffe, D. R. (2021). Feasibility and efficacy of a multicomponent exercise medicine programme in patients with pancreatic cancer undergoing neoadjuvant therapy (the EXPAN trial): Study protocol of a dual-centre, two-armed phase I randomised controlled trial. BMJ Open Gastroenterology, 8(1), article e000642. https://doi.org/10.1136/bmjgast-2021-000642

Abstract

Introduction Exercise is emerging as a therapy in oncology for its physical and psychosocial benefits and potential effects on chemotherapy tolerability and efficacy. However, evidence from randomised controlled trials (RCTs) supporting exercise in patients with borderline resectable or locally advanced pancreatic cancer (PanCa) undergoing neoadjuvant therapy (NAT) are lacking. Methods and analysis The EXPAN trial is a dual-centre, two-armed, phase I RCT. Forty patients with borderline resectable or locally advanced PanCa undergoing NAT will be randomised equally to an exercise intervention group (individualised exercise+standard NAT) or a usual care control group (standard NAT). The exercise intervention will be supervised and consist of moderate to vigorous intensity resistance and aerobic-based training undertaken two times a week for 45-60 min per session for a maximum period of 6 months. The primary outcome is feasibility. Secondary outcomes are patient-related and treatment-related endpoints, objectively measured physical function, body composition, psychological health and quality of life. Assessments will be conducted at baseline, prior to potential alteration of treatment (∼4 months postbaseline), at completion of the intervention (maximum 6 months postbaseline) and 3-month and 6-month postintervention (maximum 9 and 12 months postbaseline). Ethics and dissemination The EXPAN trial has been approved by Edith Cowan University (reference no.: 2020-02011-LUO), Sir Charles Gairdner Hospital (reference no.: RGS 03956) and St John of God Subiaco Hospital (reference no.: 1726). The study results will be presented at national/international conferences and submitted for publications in peer-reviewed journals. Trial registration number ACTRN12620001081909.

DOI

10.1136/bmjgast-2021-000642

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License

Research Themes

Health

Priority Areas

Prevention, detection and management of cancer and other chronic diseases

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