{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T02:28:56Z","timestamp":1783650536323,"version":"3.55.0"},"reference-count":37,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2022,2,23]],"date-time":"2022-02-23T00:00:00Z","timestamp":1645574400000},"content-version":"unspecified","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100018515","name":"Hamburger Krebsgesellschaft","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100018515","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,12,24]]},"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Eligibility criteria included women \u226518 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>The IG received a 12-month exercise and nutrition programme, the CG continued to follow usual care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The BENITA (Bewegungs- und Ern\u00e4hrungsintervention 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>DRKS00013231.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-054091","type":"journal-article","created":{"date-parts":[[2022,2,23]],"date-time":"2022-02-23T12:36:42Z","timestamp":1645619802000},"page":"e054091","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":33,"title":["Randomised controlled trial testing the feasibility of an exercise and nutrition intervention for patients with ovarian cancer during and after first-line chemotherapy (BENITA-study)"],"prefix":"10.1136","volume":"12","author":[{"given":"Tabea","family":"Maurer","sequence":"first","affiliation":[{"name":"Cancer Epidemiology, University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2141-2162","authenticated-orcid":false,"given":"Matthias Hans","family":"Belau","sequence":"additional","affiliation":[{"name":"Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"von Grundherr","sequence":"additional","affiliation":[{"name":"Department of Oncology, Hematology, BMT with Section Pneumology, Hubertus Wald Tumour Center, University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zoe","family":"Schlemmer","sequence":"additional","affiliation":[{"name":"Department of Gynaecology and Gynaecologic Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Patra","sequence":"additional","affiliation":[{"name":"Center for Athletic Medicine (UKE Athleticum), University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8808-6667","authenticated-orcid":false,"given":"Heiko","family":"Becher","sequence":"additional","affiliation":[{"name":"Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl-Heinz","family":"Schulz","sequence":"additional","affiliation":[{"name":"Center for Athletic Medicine (UKE Athleticum), University Medical Center Hamburg-Eppendorf, Hamburg, Germany"},{"name":"Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Birgit-Christiane","family":"Zyriax","sequence":"additional","affiliation":[{"name":"Midwifery Science\u2014Health Care Research and Prevention, Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Schmalfeldt","sequence":"additional","affiliation":[{"name":"Department of Gynaecology and Gynaecologic Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8919-1971","authenticated-orcid":false,"given":"Jenny","family":"Chang-Claude","sequence":"additional","affiliation":[{"name":"Cancer Epidemiology, University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany"},{"name":"Division of Cancer Epidemiology, DKFZ, Heidelberg, Baden-W\u00fcrttemberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,2,23]]},"reference":[{"key":"2025121400101892000_12.2.e054091.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2012.12.027"},{"key":"2025121400101892000_12.2.e054091.2","unstructured":"Robert Koch-Institute . Krebs in Deutschland 2015\/2016. Berlin, 2019."},{"key":"2025121400101892000_12.2.e054091.3","doi-asserted-by":"crossref","first-page":"458","DOI":"10.1002\/jcsm.12107","article-title":"Loss of skeletal muscle during neoadjuvant chemotherapy is related to decreased survival in ovarian cancer patients","volume":"7","author":"Rutten","year":"2016","journal-title":"J Cachexia Sarcopenia Muscle"},{"key":"2025121400101892000_12.2.e054091.4","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1016\/S1055-3207(18)30088-7","article-title":"The cancer cachexia syndrome","volume":"10","author":"Fearon","year":"2001","journal-title":"Surg Oncol Clin N Am"},{"key":"2025121400101892000_12.2.e054091.5","doi-asserted-by":"publisher","DOI":"10.1186\/s12877-019-1115-1"},{"key":"2025121400101892000_12.2.e054091.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2008.02.033"},{"key":"2025121400101892000_12.2.e054091.7","doi-asserted-by":"publisher","DOI":"10.1016\/j.jand.2014.07.005"},{"key":"2025121400101892000_12.2.e054091.8","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.051073"},{"key":"2025121400101892000_12.2.e054091.9","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-015-0513-2"},{"key":"2025121400101892000_12.2.e054091.10","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.14.6217"},{"key":"2025121400101892000_12.2.e054091.11","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-10-1173"},{"key":"2025121400101892000_12.2.e054091.12","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1016\/j.ygyno.2015.08.005","article-title":"Body mass index, physical activity and quality of life of ovarian cancer survivors: time to get moving?","volume":"139","author":"Smits","year":"2015","journal-title":"Gynecol Oncol"},{"key":"2025121400101892000_12.2.e054091.13","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2007.03.033"},{"key":"2025121400101892000_12.2.e054091.14","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1016\/j.ygyno.2020.06.485","article-title":"Physical activity and exercise in women with ovarian cancer: a systematic review","volume":"158","author":"Jones","year":"2020","journal-title":"Gynecol Oncol"},{"key":"2025121400101892000_12.2.e054091.15","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1016\/j.cct.2016.07.005","article-title":"A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: rationale and design of the lifestyle intervention for ovarian cancer enhanced survival (lives): an NRG Oncology\/Gynecologic Oncology Group (GOG-225) study","volume":"49","author":"Thomson","year":"2016","journal-title":"Contemp Clin Trials"},{"key":"2025121400101892000_12.2.e054091.16","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2020-036854","article-title":"Rationale and study protocol of the physical activity and dietary intervention in women with ovarian cancer (Padova) study: a randomised controlled trial to evaluate effectiveness of a tailored exercise and dietary intervention on body composition, physical function and fatigue in women with ovarian cancer undergoing chemotherapy","volume":"10","author":"Stelten","year":"2020","journal-title":"BMJ Open"},{"key":"2025121400101892000_12.2.e054091.17","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.14854"},{"key":"2025121400101892000_12.2.e054091.18","doi-asserted-by":"publisher","DOI":"10.1016\/0022-3999(94)00125-O"},{"key":"2025121400101892000_12.2.e054091.19","doi-asserted-by":"publisher","DOI":"10.1016\/S0261-5614(02)00214-5"},{"key":"2025121400101892000_12.2.e054091.20","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(03)00220-8"},{"key":"2025121400101892000_12.2.e054091.21","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2019.10.014"},{"key":"2025121400101892000_12.2.e054091.22","doi-asserted-by":"publisher","DOI":"10.1249\/MSS.0b013e3182399c0e"},{"key":"2025121400101892000_12.2.e054091.23","doi-asserted-by":"crossref","DOI":"10.1186\/s12885-018-4904-6","article-title":"Bioelectrical impedance analysis for monitoring cancer patients receiving chemotherapy and home parenteral nutrition","volume":"18","author":"Cotogni","year":"2018","journal-title":"BMC Cancer"},{"key":"2025121400101892000_12.2.e054091.24","doi-asserted-by":"publisher","DOI":"10.1136\/ijgc-2019-000585"},{"key":"2025121400101892000_12.2.e054091.25","doi-asserted-by":"crossref","DOI":"10.1186\/s12885-017-3337-y","article-title":"Validation of the German version of the Mediterranean diet adherence screener (MEDAS) questionnaire","volume":"17","author":"Hebestreit","year":"2017","journal-title":"BMC Cancer"},{"key":"2025121400101892000_12.2.e054091.26","doi-asserted-by":"publisher","DOI":"10.1097\/IGC.0000000000000349"},{"key":"2025121400101892000_12.2.e054091.27","doi-asserted-by":"crossref","first-page":"686","DOI":"10.1017\/S1478951519000312","article-title":"Exercise interventions for patients with advanced cancer: a systematic review of recruitment, attrition, and exercise adherence rates","volume":"17","author":"Sheill","year":"2019","journal-title":"Palliat Support Care"},{"key":"2025121400101892000_12.2.e054091.28","doi-asserted-by":"crossref","DOI":"10.1200\/jco.2015.33.15_suppl.9505","article-title":"Randomized trial of exercise on quality of life and fatigue in women diagnosed with ovarian cancer: The Women\u2019s Activity and Lifestyle Study in Connecticut (WALC)","volume":"33","author":"Zhou","year":"2015","journal-title":"Journal of Clinical Oncology"},{"key":"2025121400101892000_12.2.e054091.29","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-036854"},{"key":"2025121400101892000_12.2.e054091.30","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2407-11-389","article-title":"Safety, feasibility and effects of an individualised walking intervention for women undergoing chemotherapy for ovarian cancer: a pilot study","volume":"11","author":"Newton","year":"2011","journal-title":"BMC Cancer"},{"key":"2025121400101892000_12.2.e054091.31","doi-asserted-by":"publisher","DOI":"10.1097\/IGC.0000000000000460"},{"key":"2025121400101892000_12.2.e054091.32","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2011.04.043"},{"key":"2025121400101892000_12.2.e054091.33","doi-asserted-by":"publisher","DOI":"10.1055\/s-0033-1350713"},{"key":"2025121400101892000_12.2.e054091.34","doi-asserted-by":"crossref","first-page":"845","DOI":"10.1093\/annonc\/mdz074","article-title":"Long-Term fatigue and quality of life among epithelial ovarian cancer survivors: a GINECO case\/control VIVROVAIRE I study","volume":"30","author":"Joly","year":"2019","journal-title":"Ann Oncol"},{"key":"2025121400101892000_12.2.e054091.35","doi-asserted-by":"crossref","unstructured":"Brauns HSS , Steinmann S . The CASMIN educational classification in international comparative. research. Boston, MA: Springer, 2003.","DOI":"10.1007\/978-1-4419-9186-7_11"},{"key":"2025121400101892000_12.2.e054091.36","doi-asserted-by":"crossref","first-page":"87","DOI":"10.3802\/jgo.2015.26.2.87","article-title":"Figo's staging classification for cancer of the ovary, fallopian tube, and peritoneum: abridged republication","volume":"26","author":"Prat","year":"2015","journal-title":"J Gynecol Oncol"},{"key":"2025121400101892000_12.2.e054091.37","doi-asserted-by":"crossref","first-page":"377???381","DOI":"10.1249\/00005768-198205000-00012","article-title":"Psychophysical bases of perceived exertion","volume":"14","author":"Borg","year":"1982","journal-title":"Med Sci Sports Exerc"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-054091","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T08:10:26Z","timestamp":1765699826000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-054091"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,2]]},"references-count":37,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2022,2,23]]},"published-print":{"date-parts":[[2022,2]]}},"alternative-id":["10.1136\/bmjopen-2021-054091"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-054091","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,2]]}}}