Effectiveness of an individualized program of muscular strength and endurance with aerobic training for improving germ cell cancer-related fatigue in men undergoing chemotherapy: EFICATEST study protocol for a randomized controlled trial

BACKGROUND: Patients with testicular germ cell cancer (GCC) have a high cure rate; however, cancer-related fatigue is the most common complication among patients with GCC undergoing treatment with chemotherapy. Although exercise is widely recommended, information about the physio-pathological effects of cancer therapy on skeletal muscle is very limited. Our aim is to evaluate the effects of an individualized program of muscular strength and endurance with aerobic training on cancer-related fatigue. METHODS/DESIGN: The present study is a randomized controlled trial comparing an individualized program of muscular strength and endurance with aerobic training compared to a control group. We will conduct this trial in patients undergoing chemotherapy, recruited by the Department of Oncology of Virgen de la Victoria Hospital (Málaga). Patients will be included and evaluated before the first cycle of chemotherapy and assigned randomly to the experimental or control group. Cancer-related fatigue, physical condition and biological samples will be measured at the beginning and at the end of an 8-week intervention by the same evaluator, who will be unaware of the allocation of participants to each group. Furthermore, there will be monitoring for 6 months (24 weeks) after training for all outcome variables. DISCUSSION: This study hopes to offer patients with GCC an individualized exercise program with aerobic training for cancer-related fatigue. Such a scheme, if beneficial, could be implemented successfully within public health. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02433197. Date of registration: 13 April 2015.