Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial

Sandra Hayes; Andreas Obermair; Linda Mileshkin; Alison Davis; Louisa G Gordon; Elizabeth Eakin; Monika Janda; Vanessa L Beesley; Elizabeth H Barnes; Rosalind Renee Spence; Carolina Sandler; Tamara Jones; Dimitrios Vagenas; Penny Webb; John Andrews; Alison Brand; Yeh Chen Lee; Michael Friedlander; Kate Pumpa; Helene O'Neille; Merran Williams; ECHO Collaborative; Martin Stockler; ECHO trial

doi:10.1136/bmjopen-2022-067925

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial

BMJ Open. 2023 Apr 13;13(4):e067925. doi: 10.1136/bmjopen-2022-067925.

Authors

Sandra Hayes^{1

2

3}, Andreas Obermair⁴, Linda Mileshkin⁵, Alison Davis⁶, Louisa G Gordon⁷, Elizabeth Eakin⁸, Monika Janda⁹, Vanessa L Beesley^{10

11

12}, Elizabeth H Barnes³, Rosalind Renee Spence¹³, Carolina Sandler^{13

14}, Tamara Jones^{13

15}, Dimitrios Vagenas², Penny Webb¹⁰, John Andrews³, Alison Brand¹⁶, Yeh Chen Lee^{3

17}, Michael Friedlander¹⁷, Kate Pumpa¹⁸, Helene O'Neille¹⁹, Merran Williams¹⁹; ECHO Collaborative; Martin Stockler³; ECHO trial

Collaborators

Trudi Cattley, James Nicklin, Andrea Garrett, Piksi Singh, Jeff Goh, Catherine Shannon, Lewis Perrin, Amasy Alkhateeb, Dirkje Sommeijer, Melissa Creed, Sheree Rye, Nicole McDonald

Affiliations

¹ School of Health Sciences and Social Work, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia sandi.hayes@griffith.edu.au.
² School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia.
³ University of Sydney, NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia.
⁴ Queensland Centre for Gynaecological Cancer Research, University of Queensland, Brisbane, Queensland, Australia.
⁵ Peter MacCallum Cancer Centre, Victoria, Australia.
⁶ Department of Medical Oncology, The Canberra Hospital and ANU Medical School, Australian National University, Canberra, Australian Capital Territory, Australia.
⁷ QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.
⁸ School of Public Health, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.
⁹ Centre for Health Services Research, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.
¹⁰ Population Health Program, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.
¹¹ School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.
¹² School of Public Health, University of Queensland, Brisbane, Queensland, Australia.
¹³ School of Health Sciences and Social Work, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.
¹⁴ Sport and Exercise Science, School of Health Science, Western Sydney University, Sydney, New South Wales, Australia.
¹⁵ School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia.
¹⁶ Department of Gynaecological Oncology, Westmead Hospital, Westmead, New South Waled and University of Sydney, Sydney, New South Wales, Australia.
¹⁷ Prince of Wales Clinical School, Faculty of Medicine and Health, University of New South Wales, Randwick, New South Wales, Australia.
¹⁸ Research Institute for Sport and Exercise, University of Canberra, Canberra, Australian Capital Territory, Australia.
¹⁹ Consumer representatives, Brisbane, Queensland, Australia.

Abstract

Introduction: Epidemiological evidence supports an association between higher levels of physical activity and improved cancer survival. Trial evidence is now needed to demonstrate the effect of exercise in a clinical setting. The Exercise during CHemotherapy for Ovarian cancer (ECHO) trial is a phase III, randomised controlled trial, designed to determine the effect of exercise on progression-free survival and physical well-being for patients receiving first-line chemotherapy for ovarian cancer.

Methods and analysis: Participants (target sample size: n=500) include women with newly diagnosed primary ovarian cancer, scheduled to receive first-line chemotherapy. Consenting participants are randomly allocated (1:1) to either the exercise intervention (plus usual care) or usual care alone, with stratification for recruitment site, age, stage of disease and chemotherapy delivery (neoadjuvant vs adjuvant). The exercise intervention involves individualised exercise prescription with a weekly target of 150 minutes of moderate-intensity, mixed-mode exercise (equivalent to 450 metabolic equivalent minutes per week), delivered for the duration of first-line chemotherapy through weekly telephone sessions with a trial-trained exercise professional. The primary outcomes are progression-free survival and physical well-being. Secondary outcomes include overall survival, physical function, body composition, quality of life, fatigue, sleep, lymphoedema, anxiety, depression, chemotherapy completion rate, chemotherapy-related adverse events, physical activity levels and healthcare usage.

Ethics and dissemination: Ethics approval for the ECHO trial (2019/ETH08923) was granted by the Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Zone) on 21 November 2014. Subsequent approvals were granted for an additional 11 sites across Queensland, New South Wales, Victoria and the Australian Capital Territory. Findings from the ECHO trial are planned to be disseminated via peer-reviewed publications and international exercise and oncology conferences.

Trial registration number: Australian New Zealand Clinical Trial Registry (ANZCTRN12614001311640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367123&isReview=true).

Keywords: GYNAECOLOGY; ONCOLOGY; PUBLIC HEALTH.

Publication types

Randomized Controlled Trial
Clinical Trial, Phase III
Research Support, Non-U.S. Gov't

MeSH terms

Australia
Exercise
Exercise Therapy
Female
Humans
Ovarian Neoplasms* / drug therapy
Quality of Life*