Design of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES):A randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue

This multicenter, prospective, randomized trial will evaluate the effectiveness of a low to moderate intensity, home-based, self-management physical activity program, and a high intensity, structured, supervised exercise program, in maintaining or enhancing physical fitness (cardiorespiratory fitness and muscle strength), in minimizing fatigue and in enhancing the health-related quality of life (HRQoL). Patients receiving adjuvant chemotherapy for breast or colon cancer (n = 360) are being recruited from twelve hospitals in the Netherlands, and randomly allocated to one of the two treatment groups or to a 'usual care' control group. Performance-based and self-reported outcomes are assessed at baseline, at the end of chemotherapy and at six month follow-up.This large, multicenter, randomized clinical trial will provide additional empirical evidence regarding the effectiveness of physical exercise during adjuvant chemotherapy in enhancing physical fitness, minimizing fatigue, and maintaining or enhancing patients' quality of life. If demonstrated to be effective, exercise intervention programs will be a welcome addition to the standard program of care offered to patients with cancer receiving chemotherapy.This study is registered at the Netherlands Trial Register (NTR 2159)Treatment with chemotherapy is associated with multiple physical and psychosocial side effects, including reduced cardiorespiratory fitness and muscle strength and increased fatigue [1,2]. Fatigue is a common problem reported by patients undergoing chemotherapy, with prevalence rates ranging from 80% to 100% [3-5]. Among breast cancer survivors, the prevalence of chronic, severe fatigue has been reported to range from 24% to 40%. Chronic fatigue has a negative impact on activities of daily life, social reintegration and overall quality of life [3]. Fatigue and muscle wasting may be directly therapy-induced, but may also be attributed in part to sedentary habits and subsequent loss of physical fitnes