Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial
Andreas Obermair,
Monika Janda,
Linda Mileshkin,
Alison Davis,
Elizabeth H Barnes,
Kate Pumpa,
Elizabeth Eakin,
Martin Stockler,
Alison Brand,
Lewis Perrin,
Michael Friedlander,
Sandra Hayes,
Andrea Garrett,
Piksi Singh,
Tamara Jones,
Dimitrios Vagenas,
Carolina Sandler,
Louisa G Gordon,
Catherine Shannon,
James Nicklin,
Yeh Chen Lee,
John Andrews,
Nicole McDonald,
Vanessa L Beesley,
Rosalind Renee Spence,
Penny Webb,
Helene O’Neille,
Merran Williams,
Trudi Cattley,
Jeff Goh,
Amasy Alkhateeb,
Dirkje Sommeijer,
Melissa Creed,
Sheree Rye
Affiliations
Andreas Obermair
Faculty of Medicine, The University of Queensland Centre for Clinical Research, Herston, Queensland, Australia
Monika Janda
5Univerity of Queensland, Centre For Health Services Research, Woolloongabba, Australia
Linda Mileshkin
Department of Medical Oncology, Peter MacCallum Cancer Centre, Parkville, Victoria, Australia
Alison Davis
Department of Medical Oncology, The Canberra Hospital and ANU Medical School, Australian National University, Canberra, Australian Capital Territory, Australia
Elizabeth H Barnes
7 NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia
Kate Pumpa
University College Dublin, Dublin, Ireland
Elizabeth Eakin
Faculty of Medicine, School of Public Health, The University of Queensland, Brisbane, Queensland, Australia
Martin Stockler
3 NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia
Alison Brand
Department of Gynaecological Oncology, Westmead Hospital, Westmead, New South Waled and University of Sydney, Sydney, New South Wales, Australia
Lewis Perrin
Michael Friedlander
34 Department of Medical Oncology, Prince of Wales and Royal Hospital for Women, Randwick, New South Wales, Australia
Sandra Hayes
School of Health Sciences and Social Work, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
Andrea Garrett
Queensland Centre for Gynaecological Cancer Research, Royal Brisbane and Women`s Hospital, Herston, Queensland, Australia
Piksi Singh
Tamara Jones
School of Health Sciences and Social Work, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
Dimitrios Vagenas
School of Public Health and Social Work, Queensland University of Technology Faculty of Health, Kelvin Grove, Queensland, Australia
Carolina Sandler
School of Health Sciences and Social Work, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
Louisa G Gordon
3 School of Public Health, The University of Queensland, Brisbane, Queensland, Australia
Catherine Shannon
Queensland Centre for Gynaecological Cancer Research, The University of Queensland, Herston, Queensland, Australia
James Nicklin
Gynaecological Cancer, Royal Brisbane and Women`s Hospital, Herston, Queensland, Australia
Yeh Chen Lee
Department of Medical Oncology, Prince of Wales Hospital Nelune Comprehensive Cancer Centre, Randwick, New South Wales, Australia
John Andrews
University of Sydney, NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia
Nicole McDonald
Vanessa L Beesley
Population Health Program, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia
Rosalind Renee Spence
School of Health Sciences and Social Work, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
Penny Webb
Population Health Program, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia
Helene O’Neille
Consumer representatives, Brisbane, Queensland, Australia
Merran Williams
Queensland Centre for Gynaecological Cancer Research, The University of Queensland, Herston, Queensland, Australia
Trudi Cattley
Jeff Goh
Amasy Alkhateeb
Dirkje Sommeijer
Melissa Creed
Sheree Rye
School of Health Sciences and Social Work, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia
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).
