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@ARTICLE{Oberste:141687,
      author       = {M. Oberste and N. Schaffrath and K. Schmidt and W. Bloch
                      and E. Jäger and K. Steindorf$^*$ and P. Hartig and N.
                      Joisten and P. Zimmer$^*$},
      title        = {{P}rotocol for the '{C}hemobrain in {M}otion - study'
                      ({CIM} - study): a randomized placebo-controlled trial of
                      the impact of a high-intensity interval endurance training
                      on cancer related cognitive impairments in women with breast
                      cancer receiving first-line chemotherapy.},
      journal      = {BMC cancer},
      volume       = {18},
      number       = {1},
      issn         = {1471-2407},
      address      = {Heidelberg},
      publisher    = {Springer},
      reportid     = {DKFZ-2018-01958},
      pages        = {1071},
      year         = {2018},
      abstract     = {Up to $80\%$ of breast cancer patients suffer from Cancer
                      Related Cognitive Impairments (CRCI). Exercise is suggested
                      as a potential supportive care option to reduce cognitive
                      decline in cancer patients. This study will investigate the
                      effects of a high-intensity interval endurance training
                      (HIIT) on CRCI in breast cancer patients. Potentially
                      underlying immunological and neurobiological mechanisms, as
                      well as effects on patients' self-perceived cognitive
                      functioning and common cancer related side-effects, will be
                      explored.A single-blinded randomized controlled trial will
                      be carried out. The impact of HIIT on CRCI will be compared
                      to that of a placebo-intervention (supervised myofascial
                      release training). Both interventions will be conducted
                      simultaneously with the patients' first-line chemotherapy
                      treatment typically lasting 12-18 weeks. Fifty-nine women
                      with breast cancer will be included in each of the two
                      groups. The study is powered to detect (α = .05,
                      β = .2) a medium effect size difference between the two
                      groups (d = .5) in terms of patients' change in
                      cognitive testing performances, from baseline until the end
                      of the exercise-intervention. The cognitive test battery,
                      recommended by the International Cancer and Cognition Task
                      Force to assess CRCI, will be used as primary measure. This
                      includes the Hopkins Verbal Learning Test (learning/verbal
                      memory), the Controlled Oral Word Association Test (verbal
                      fluency) and the Trail-Making-Test A/B
                      (attention/set-switching). The following endpoints will be
                      assessed as secondary measures: Go-/No-Go test performance
                      (response inhibition), self-perceived cognitive functioning,
                      serum levels of pro- and antiinflammatory markers (tumor
                      necrosis factor alpha, Interleukin-6, Interleukin-1 alpha,
                      Interleukin-1 beta, C-reactive protein, Interleukin-1
                      receptor antagonist and Interleukin-10), serum levels of
                      neurotrophic and growth factors (brain-derived neurotrophic
                      factor, insulin-like growth factor 1 and vascular
                      endothelial growth factor), as well as common cancer-related
                      side effects (decrease in physical capacity, fatigue,
                      anxiety and depression, sleep disturbances, quality of life
                      and chemotherapy compliance).This study will provide data on
                      the question whether HIIT is an effective supportive therapy
                      that alleviates CRCI in breast cancer patients. Moreover,
                      the present study will help shed light on the underlying
                      mechanisms of potential CRCI improving effects of exercise
                      in breast cancer patients.DRKS.de, German Clinical Trials
                      Register (DRKS), ID: DRKS00011390 , Registered on 17 January
                      2018.},
      cin          = {G210},
      ddc          = {610},
      cid          = {I:(DE-He78)G210-20160331},
      pnm          = {317 - Translational cancer research (POF3-317)},
      pid          = {G:(DE-HGF)POF3-317},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:30400840},
      pmc          = {pmc:PMC6220507},
      doi          = {10.1186/s12885-018-4992-3},
      url          = {https://inrepo02.dkfz.de/record/141687},
}