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.