Adapted Physical Activity and Diet (APAD) During Adjuvant Breast Cancer Therapy: Design and Implementation of a Prospective Randomized Controlled Trial

Exercise practice and appropriate nutrition have been advanced as non pharmacological supportive care to reduce side effects related to cancer and its treatment, but large sample-sized randomized controlled trials are needed to confirm such results. The Adapted Physical Activity and Diet counseling (APAD) study is a prospective randomized controlled trial designed to evaluate the effectiveness of a 26-week hospital- and home-based lifestyle intervention on cancer-related fatigue in women receiving breast cancer adjuvant treatment (chemotherapy and radiotherapy). The aim of this paper is to describe the APAD study protocol. Study recruitment goal is 264 adult breast cancer women with newly, histologically proven, incident and non metastatic breast cancer scheduled for 6 cycles of adjuvant chemotherapy followed by radiotherapy. Patients are randomized either in the experimental arm with tailored exercise training and diet counseling program or in the control arm without any lifestyle intervention (usual care). Outcome measures are collected at baseline, and at 15 weeks (i.e., mid-intervention), 26 weeks (i.e., immediately post-intervention), and at 12-month and 18-month of follow-up. Intervention effect is assessed on fatigue (emotional, cognitive, physical), quality-of-life, anxiety, depression, body weight and composition. In addition, levels of physical activity, dietary intakes and adjuvant therapy observance are measured and a cost-utility analysis will be performed. If improvements in fatigue, quality-of-life and a better weight control are observed, the APAD study could demonstrate the feasibility and the effectiveness of such exercise and nutrition supportive care with limited additional cost in patients receiving adjuvant breast cancer therapy.