title: Progressive resistance training and cancer testis (PROTRACT) - efficacy of resistance training on muscle function, morphology and inflammatory profile in testicular cancer patients undergoing chemotherapy: design of a randomized controlled trial.
abstract: BACKGROUND
  Standard treatment for patients with disseminated germ cell tumors is combination chemotherapy with bleomycin, etoposide and cisplatin (BEP). This treatment is highly effective, but the majority of patients experience severe adverse effects during treatment and are at risk of developing considerable long-term morbidity, including second malignant neoplasms, cardiovascular disease, and pulmonary toxicity. One neglected side effect is the significant muscular fatigue mentioned by many patients with testicular cancer both during and after treatment. Very limited information exists concerning the patho-physiological effects of antineoplastic agents on skeletal muscle. The primary aim of this study is to investigate the effects of BEP-treatment on the skeletal musculature in testicular cancer patients, and to examine whether the expected treatment-induced muscular deterioration can be attenuated or even reversed by high intensity progressive resistance training (HIPRT).
  
  
  METHODS
  The PROTRACT study is a randomized controlled trial in 30 testicular cancer patients undergoing three cycles of BEP chemotherapy. Participants will be randomized to either a 9-week HIPRT program (STR) initiated at the onset of treatment, or to standard care (UNT). 15 healthy matched control subjects (CON) will complete the same HIPRT program. All participants will take part in 3 assessment rounds (baseline, 9 wks, 21 wks) including muscle biopsies, maximum muscle strength tests, whole body DXA scan and blood samples.
  
  
  METHODS
  mean fiber area and fiber type composition measured by histochemical analyses, satellite cells and levels of protein and mRNA expression of intracellular mediators of protein turnover.
  
  
  RESULTS
  maximum muscle strength and muscle power measured by maximum voluntary contraction and leg-extensor-power tests, body composition assessed by DXA scan, and systemic inflammation analyzed by circulating inflammatory markers, lipid and glucose metabolism in blood samples. Health related Quality of Life (QoL) will be assessed by validated questionnaires (EORTC QLQ-C30, SF-36).
  
  
  CONCLUSIONS
  This study investigates the muscular effects of antineoplastic agents in testicular cancer patients, and furthermore evaluates whether HIPRT has a positive influence on side effects related to chemotherapy. A more extensive knowledge of the interaction between cytotoxic-induced physiological impairment and exercise-induced improvement is imperative for the future development of optimal rehabilitation programs for cancer patients.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN32132990.
authors.affiliation: University Hospital Centre for Nursing and Care Research, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark. jfc@rh.regionh.dk
authors.forename: Jesper F
authors.initials: JF
authors.lastname: Christensen
authors.forename: Jesper L
authors.initials: JL
authors.lastname: Andersen
authors.forename: Lis
authors.initials: L
authors.lastname: Adamsen
authors.forename: Birgitte
authors.initials: B
authors.lastname: Lindegaard
authors.forename: Abigail L
authors.initials: AL
authors.lastname: Mackey
authors.forename: Rie H
authors.initials: RH
authors.lastname: Nielsen
authors.forename: Mikael
authors.initials: M
authors.lastname: Rørth
authors.forename: Gedske
authors.initials: G
authors.lastname: Daugaard
mesh_terms: D000704:Analysis of Variance; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001761:Bleomycin / Q000009:adverse effects / Q000627:therapeutic use; D016022:Case-Control Studies; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D005047:Etoposide / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D018908:Muscle Weakness / Q000139:chemically induced / Q000517:prevention & control / Q000628:therapy*; D015203:Reproducibility of Results; D012107:Research Design; D055070:Resistance Training; D011795:Surveys and Questionnaires; D013736:Testicular Neoplasms / Q000188:drug therapy / Q000628:therapy*
chemical_list: D000970:Antineoplastic Agents; D001761:Bleomycin; D005047:Etoposide; D002945:Cisplatin