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@ARTICLE{Schttker:157452,
      author       = {B. Schöttker$^*$ and S. Kuznia$^*$ and D. C. Laetsch$^*$
                      and D. Czock and A. Kopp-Schneider$^*$ and R. Caspari and H.
                      Brenner$^*$},
      title        = {{P}rotocol of the {VICTORIA} study: personalized vitamin
                      {D} supplementation for reducing or preventing fatigue and
                      enhancing quality of life of patients with colorectal tumor
                      - randomized intervention trial.},
      journal      = {BMC cancer},
      volume       = {20},
      number       = {1},
      issn         = {1471-2407},
      address      = {Heidelberg},
      publisher    = {Springer},
      reportid     = {DKFZ-2020-01631},
      pages        = {739},
      year         = {2020},
      note         = {#EA:C070#LA:C070},
      abstract     = {Cancer-related fatigue represents one major cause of
                      reduced quality of life in cancer patients and can seriously
                      affect the physical, emotional, and cognitive functioning
                      impeding coping with the disease. Options for effective
                      treatment of cancer-related fatigue are limited, consisting
                      only of non-pharmacologic interventions like physical
                      activity, psychosocial, and mind-body interventions. Recent
                      evidence suggests that vitamin D3 supplementation might
                      alleviate cancer-related fatigue. However, confirmation in a
                      randomized controlled trial is needed.In this multicenter,
                      randomized, double-blind, placebo-controlled trial, 456
                      colorectal cancer (CRC) patients aged 18 years and older
                      are being recruited in three German rehabilitation clinics.
                      Study inclusion requires hospitalization of at least 3 weeks
                      at such a clinic, a diagnosis of non-metastatic CRC (stage
                      I-III), surgical removal of the tumor within the past 9
                      months, and season-adapted vitamin D insufficiency or
                      deficiency. Eligible patients are randomly assigned to a
                      personalized regimen of vitamin D3 or placebo for
                      12 weeks. In the intervention group, a loading dose of
                      20,000 or 40,000 IU vitamin D3 will be administered daily
                      during the first 11 days, followed by a maintenance dose
                      of 2000 IU daily. Patients will complete questionnaires
                      for secondary outcomes (fatigue subdomains, quality of life
                      and subdomains, depression, functional well-being, and
                      infection frequency). Blood and urine samples will be
                      collected for analyses of safety parameters
                      (hypervitaminosis D, hypercalcemia, hypercalciuria, and
                      renal impairment) and efficacy biomarkers (25-hydroxyvitamin
                      D, HbA1c, white blood cell count, leukocyte subtype counts,
                      serum C-reactive protein, uric acid, creatinine,
                      triglycerides, total, low- and high-density lipoprotein
                      cholesterol).This trial tests whether a personalized vitamin
                      D3 dosing regimen reduces or prevents fatigue among
                      non-metastatic CRC patients by treating the underlying
                      vitamin D deficiency/insufficiency. If efficacy can be
                      confirmed, personalized vitamin D3 supplementation could be
                      used as a tertiary prevention measure in addition to
                      non-pharmacological treatments of cancer-related fatigue in
                      CRC patients. We expect to detect an effect of vitamin D3
                      supplementation on secondary outcomes like quality of life,
                      depression, functional well-being, infections, inflammatory
                      biomarkers, diabetes mellitus, and dyslipidemia.European
                      Clinical Trials Database: EudraCT-No: 2019-000502-30,
                      January 21, 2019; German Clinical Trials Register (DRKS):
                      DRKS00019907 , April 30, 2019.},
      subtyp        = {Review Article},
      cin          = {C070 / C060 / C120 / HD01},
      ddc          = {610},
      cid          = {I:(DE-He78)C070-20160331 / I:(DE-He78)C060-20160331 /
                      I:(DE-He78)C120-20160331 / I:(DE-He78)HD01-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:32770972},
      pmc          = {pmc:PMC7414549},
      doi          = {10.1186/s12885-020-07219-z},
      url          = {https://inrepo02.dkfz.de/record/157452},
}