Exercise during chemotherapy for recurrent ovarian cancer (ECHO-R): A Phase II trial evaluating feasibility, safety and efficacy of an individually-tailored exercise intervention during chemotherapy for recurrent ovarian cancer

Abstract

Introduction & Aims: Women with recurrent ovarian cancer (ROC) have poor quality of life (QOL), physical well-being, function, and high unmet supportive care needs. COSA recommends exercise for all people with cancer. However, the evidence supporting exercise as being safe, feasible and important for people with cancers associated with low survival rates and high morbidity, such as ROC, is limited.

Methods: ECHO-R is a national, single-arm trial evaluating the feasibility, safety, and preliminary efficacy of an exercise intervention during chemotherapy for ROC (n = 80). The 6-month exercise intervention includes an individualised prescription of aerobic and resistance exercise at moderate-intensity, accumulating ≥150 min per week (in-line with COSA recommendations). The intervention is delivered via 12 telephone/video-call sessions with a study-trained exercise professional, and when accessible, is supported through the provision of an additional 5 face-to-face sessions with a community-based Accredited Exercise Physiologist. Primary outcomes of interest are (i) feasibility as assessed by retention, adherence, and compliance (deemed acceptable when >75%); and (ii) safety: measured by adverse event occurrence and characteristics, as reported by participants or exercise professional and described by the rate of exercise-related adverse events (i. ≥grade 3, ii. grade 1–2 that require ≥2-week exercise modification). Secondary outcomes of interest are assessed using validated questionnaires and/or objectively-assessed at baseline (pre-intervention), and 6- and 9-months post-baseline, and include QOL, ovarian symptoms and treatment concerns, fatigue, sleep, peripheral neuropathy, mood, hope, body composition, and function. Changes in secondary outcomes will be analysed using generalised estimating equations to determine time effects and to explore the relationship between patient, treatment and behavioural characteristics and time effects.

Conclusion: ECHO-R will determine whether exercise is feasible and safe for women receiving treatment for ROC and will use effect findings to explore whether the COSA exercise and cancer position statement is applicable to this under-studied cancer group.