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@ARTICLE{Maurer:178922,
      author       = {T. Maurer and M. H. Belau and J. von Grundherr and Z.
                      Schlemmer and S. Patra and H. Becher and K.-H. Schulz and
                      B.-C. Zyriax and B. Schmalfeldt and J. Chang-Claude$^*$},
      title        = {{R}andomised controlled trial testing the feasibility of an
                      exercise and nutrition intervention for patients with
                      ovarian cancer during and after first-line chemotherapy
                      ({BENITA}-study).},
      journal      = {BMJ open},
      volume       = {12},
      number       = {2},
      issn         = {2044-6055},
      address      = {London},
      publisher    = {BMJ Publishing Group},
      reportid     = {DKFZ-2022-00349},
      pages        = {e054091},
      year         = {2022},
      note         = {#LA:C020#},
      abstract     = {Advanced ovarian cancer is a severe disease with major side
                      effects caused by peritoneal carcinomatosis, ascites and
                      gastrointestinal involvement as well as exhaustive treatment
                      like debulking surgery and combination chemotherapy. Two
                      most frequently reported side effects are muscle wasting and
                      malnutrition, leading to frailty, decreased health-related
                      quality of life (HRQoL) and cancer-related fatigue (CRF). As
                      muscle wasting and malnutrition often commence during
                      first-line chemotherapy and develop progressively into a
                      refractory state, an early intervention is warranted. This
                      pilot study aimed to evaluate the safety and acceptance of a
                      combined exercise and nutrition intervention during and
                      after first-line chemotherapy.The pilot study was conducted
                      as a monocentric 1:1 randomised controlled trial (RCT) with
                      an intervention group (IG) and a control group (CG).
                      Participants were divided by chance into IG or CG.
                      Information on group allocation was conveyed to the study
                      coordinator responsible for making an appointment with the
                      patients for the baseline assessment as well as the
                      physiotherapist and nutritionist responsible for the
                      intervention and outcome assessment in both
                      groups.Eligibility criteria included women ≥18 years of
                      age, diagnosed with ovarian cancer, tubal cancer or
                      peritoneal cancer and primary or interval debulking,
                      scheduled but not started adjuvant or neoadjuvant
                      chemotherapy and sufficient German-language skills.The IG
                      received a 12-month exercise and nutrition programme, the CG
                      continued to follow usual care.Primary outcomes were
                      recruitment rate, adherence to intervention, completion rate
                      and adverse events. In addition, in-person assessments (eg,
                      HRQoL, CRF, muscle quality and function and dietary intake
                      and quality) were conducted at baseline (T0, before
                      chemotherapy), week 9 (T1, mid-chemotherapy), week 19 (T2,
                      after completion of chemotherapy) and after 12 months of
                      intervention (T3).Of 60 eligible patients, 15 patients
                      signed informed consent (recruitment $rate=25.0\%)$ and were
                      randomised into IG (n=8) and CG (n=7). Eleven participants
                      completed the study (completion rate, $73.3\%),$ one patient
                      dropped out due to loss of interest, one due to poor health,
                      one was lost to follow-up and one patient died.The BENITA
                      (Bewegungs- und Ernährungsintervention bei Ovarialkrebs)
                      study demonstrated the safety and acceptance of an exercise
                      and nutrition intervention integrated into first-line
                      therapy and follow-up care of ovarian cancer. A large
                      multicentre RCT is planned to investigate the effectiveness
                      of the intervention on HRQoL, CRF and survival and to
                      establish means of implementation into oncology guidelines
                      and clinic routine.DRKS00013231.},
      keywords     = {adult oncology (Other) / epidemiology (Other) /
                      gynaecological oncology (Other)},
      cin          = {C020},
      ddc          = {610},
      cid          = {I:(DE-He78)C020-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:35197344},
      doi          = {10.1136/bmjopen-2021-054091},
      url          = {https://inrepo02.dkfz.de/record/178922},
}