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

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.

Figure 1

Participant flow through the Exercise during CHemotherapy for Ovarian cancer trial. ^aRegistration includes randomisation with stratification for recruitment site, age (<70 vs ≥70 years), stage of disease (I–II vs III–IV) and chemotherapy delivery (adjuvant vs neoadjuvant plus adjuvant). Staff involved with baseline assessments and participants remain blinded to randomisation outcome at this stage. ^bStaff involved with data collection remain blinded to randomisation outcome. ^cProgression status and survival status will be updated periodically throughout trial duration and at approximately 6 months prior to end of trial. MET, metabolic equivalent.

Figure 2

Trial assessment schedule and timing of intervention for women who receive surgery plus adjuvant chemotherapy versus women who receive neoadjuvant chemotherapy, surgery plus adjuvant chemotherapy. ^aParticipant may commence chemotherapy prior to intervention commencement (intervention commencement is anchored to baseline assessment). Intervention may continue beyond 6 months post-randomisation assessment if treatment delays occur. ^bTypically six cycles of chemotherapy scheduled over 18 weeks. ^cTypically three cycles of neoadjuvant chemotherapy scheduled over 9 weeks, followed by three cycles of adjuvant chemotherapy scheduled over 9 weeks.