title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02433197 . Date of registration: 13 April 2015.
authors.affiliation: Department of Physiotherapy, Faculty of Health Sciences, Instituto de Investigacion de Biomedicina de Malaga (IBIMA), Universidad de Malaga, Málaga, Spain. acuesta.var@gmail.com.|School of Clinical Science, Faculty of Health, Queensland University of Technology, Kelvin Grove, QLD, Australia. acuesta.var@gmail.com.
authors.forename: Antonio Ignacio
authors.initials: AI
authors.lastname: Cuesta-Vargas
authors.affiliation: Department of Medical Oncology, Carlos Haya Regional University Hospital, Málaga, Spain. fcarabantes@hotmail.com.
authors.forename: Francisco
authors.initials: F
authors.lastname: Carabantes
authors.affiliation: Department of Cellular Biology, Genetics and Physiology, Faculty of Sciences, Universidad de Malaga, Málaga, Spain. Zacari@hcs.es.
authors.forename: Zaira
authors.initials: Z
authors.lastname: Caracuel
authors.affiliation: Department of Physiotherapy, Faculty of Health Sciences, Instituto de Investigacion de Biomedicina de Malaga (IBIMA), Universidad de Malaga, Málaga, Spain. inmaconejo@gmail.com.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Conejo
authors.affiliation: Department of Medical Oncology, Carlos Haya Regional University Hospital, Málaga, Spain. ealbac@uma.es.
authors.forename: Emilio
authors.initials: E
authors.lastname: Alba
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D015444:Exercise; D005221:Fatigue / Q000628:therapy*; D006801:Humans; D008297:Male; D055432:Metabolomics; D008875:Middle Aged; D053580:Muscle Strength; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000503:physiopathology; D010807:Physical Endurance; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000503:physiopathology