Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial—the PREHAB study
IntroductionPerioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new conce...
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| creator | Le Roy, Bertrand Pereira, Bruno Bouteloup, Corinne Costes, Frédéric Richard, Ruddy Selvy, Marie Pétorin, Caroline Gagnière, Johan Futier, Emmanuel Slim, Karem Meunier, Bernard Mabrut, Jean-Yves Mariette, Christophe Pezet, Denis |
| description | IntroductionPerioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based on 3 components: (1) physical management, (2) nutritional care and (3) psychological care. Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment.Methods and analysisThe PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy. This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. Patients (n=60 per group) will be randomly assigned for management with either prehabilitation or conventional care. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, overall survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy (defined by the VO2peak, ventilatory threshold and 6-min walk test), preoperative and postoperative nutritional status, preoperative anxiety, quality of life, 30-day and 90-day mortality and cumulative dose of cytotoxic treatment received.Ethics and disseminationThe study was approved by an independent medical ethics committee (IRB00008526, CPP Sud-Est VI, Clermont-Ferrand, France) and by the competent French authority (ANSM, Saint Denis, France) and registered on Clinicaltrial.gov. The results will be disseminated in a peer-reviewed journal.Trial registration numberNCT02780921. |
| doi_str_mv | 10.1136/bmjopen-2016-012876 |
| format | Article |
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However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based on 3 components: (1) physical management, (2) nutritional care and (3) psychological care. Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment.Methods and analysisThe PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy. This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. Patients (n=60 per group) will be randomly assigned for management with either prehabilitation or conventional care. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, overall survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy (defined by the VO2peak, ventilatory threshold and 6-min walk test), preoperative and postoperative nutritional status, preoperative anxiety, quality of life, 30-day and 90-day mortality and cumulative dose of cytotoxic treatment received.Ethics and disseminationThe study was approved by an independent medical ethics committee (IRB00008526, CPP Sud-Est VI, Clermont-Ferrand, France) and by the competent French authority (ANSM, Saint Denis, France) and registered on Clinicaltrial.gov. The results will be disseminated in a peer-reviewed journal.Trial registration numberNCT02780921.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2016-012876</identifier><identifier>PMID: 27927660</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Adenocarcinoma - complications ; Adenocarcinoma - physiopathology ; Adenocarcinoma - therapy ; Aged ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Anxiety ; Chemotherapy ; Clinical trials ; Compliance ; Consent ; Esophageal cancer ; Esophageal Neoplasms - complications ; Esophageal Neoplasms - physiopathology ; Esophageal Neoplasms - therapy ; Exercise ; Female ; Food and Nutrition ; France ; Human health and pathology ; Humans ; Intervention ; Life Sciences ; Male ; Middle Aged ; Morbidity ; Mortality ; Nutrition ; Nutrition Therapy ; Nutritional status ; Nutritionists ; Patients ; Physical fitness ; Physical therapists ; Postoperative Complications - prevention & control ; Preoperative Care - methods ; Prospective Studies ; Proteins ; Psychologists ; Quality of Life ; Stomach Neoplasms - complications ; Stomach Neoplasms - physiopathology ; Stomach Neoplasms - therapy ; Surgeons ; Surgery ; Treatment Outcome</subject><ispartof>BMJ open, 2016-12, Vol.6 (12), p.e012876-e012876</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016 This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b506t-1e943be3b5d178f187bdaac23192a1294240b4e277dd71a3b0daef28ad60246b3</citedby><cites>FETCH-LOGICAL-b506t-1e943be3b5d178f187bdaac23192a1294240b4e277dd71a3b0daef28ad60246b3</cites><orcidid>0000-0002-4668-9275 ; 0000-0003-3778-7161 ; 0000-0002-6454-271X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmjopen.bmj.com/content/6/12/e012876.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmjopen.bmj.com/content/6/12/e012876.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27526,27527,27901,27902,53766,53768,77343,77374</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27927660$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-01465152$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Le Roy, Bertrand</creatorcontrib><creatorcontrib>Pereira, Bruno</creatorcontrib><creatorcontrib>Bouteloup, Corinne</creatorcontrib><creatorcontrib>Costes, Frédéric</creatorcontrib><creatorcontrib>Richard, Ruddy</creatorcontrib><creatorcontrib>Selvy, Marie</creatorcontrib><creatorcontrib>Pétorin, Caroline</creatorcontrib><creatorcontrib>Gagnière, Johan</creatorcontrib><creatorcontrib>Futier, Emmanuel</creatorcontrib><creatorcontrib>Slim, Karem</creatorcontrib><creatorcontrib>Meunier, Bernard</creatorcontrib><creatorcontrib>Mabrut, Jean-Yves</creatorcontrib><creatorcontrib>Mariette, Christophe</creatorcontrib><creatorcontrib>Pezet, Denis</creatorcontrib><title>Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial—the PREHAB study</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionPerioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based on 3 components: (1) physical management, (2) nutritional care and (3) psychological care. Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment.Methods and analysisThe PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy. This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. Patients (n=60 per group) will be randomly assigned for management with either prehabilitation or conventional care. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, overall survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy (defined by the VO2peak, ventilatory threshold and 6-min walk test), preoperative and postoperative nutritional status, preoperative anxiety, quality of life, 30-day and 90-day mortality and cumulative dose of cytotoxic treatment received.Ethics and disseminationThe study was approved by an independent medical ethics committee (IRB00008526, CPP Sud-Est VI, Clermont-Ferrand, France) and by the competent French authority (ANSM, Saint Denis, France) and registered on Clinicaltrial.gov. The results will be disseminated in a peer-reviewed journal.Trial registration numberNCT02780921.</description><subject>Adenocarcinoma - complications</subject><subject>Adenocarcinoma - physiopathology</subject><subject>Adenocarcinoma - therapy</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Anxiety</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Compliance</subject><subject>Consent</subject><subject>Esophageal cancer</subject><subject>Esophageal Neoplasms - complications</subject><subject>Esophageal Neoplasms - physiopathology</subject><subject>Esophageal Neoplasms - therapy</subject><subject>Exercise</subject><subject>Female</subject><subject>Food and Nutrition</subject><subject>France</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Intervention</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Morbidity</subject><subject>Mortality</subject><subject>Nutrition</subject><subject>Nutrition Therapy</subject><subject>Nutritional status</subject><subject>Nutritionists</subject><subject>Patients</subject><subject>Physical fitness</subject><subject>Physical therapists</subject><subject>Postoperative Complications - prevention & control</subject><subject>Preoperative Care - methods</subject><subject>Prospective Studies</subject><subject>Proteins</subject><subject>Psychologists</subject><subject>Quality of Life</subject><subject>Stomach Neoplasms - complications</subject><subject>Stomach Neoplasms - physiopathology</subject><subject>Stomach Neoplasms - therapy</subject><subject>Surgeons</subject><subject>Surgery</subject><subject>Treatment Outcome</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNktGK1DAUhoso7rLuEwgS8EZhuyZpmrReCOMyOsKAInodTpN0JkPb1CRd2DufwCuf0CcxteOy7pW5STj5_j_nhD_LnhJ8SUjBXzX9wY1myCkmPMeEVoI_yE4pZiznuCwf3jmfZOchHHBarKzLkj7OTqioqeAcn2Y_1m1rVESuRaM3e2hsZyNE6wZkB7SDEL3LnQlu3MPOQIdAm8Ep8MoOrofXKMRJ3ySti065bvYB1E9dtMoM0Vt1gTwM2vU2GH2BlEvFhKUb6H59_xn3Bn36vN6s3i5GT7JHLXTBnB_3s-zru_WXq02-_fj-w9Vqmzcl5jEnpmZFY4qm1ERULalEowEULUhNgdCaUYYbZqgQWgsCRYM1mJZWoDmmjDfFWfZm8R2npjf6T6_QydHbHvyNdGDlvzeD3cudu5Yl4RUXPBm8XAz292Sb1VbONUwYL0lJr0liXxwf8-7bZEKU6TeU6ToYjJuCJBUTVYWxqBP6_B56cJMf0lfMFOdpelIkqlgo5V0I3rS3HRAs53jIYzzkHA-5xCOpnt2d-VbzNwwJuFyApP4vx98oScmP</recordid><startdate>20161207</startdate><enddate>20161207</enddate><creator>Le Roy, Bertrand</creator><creator>Pereira, Bruno</creator><creator>Bouteloup, Corinne</creator><creator>Costes, Frédéric</creator><creator>Richard, Ruddy</creator><creator>Selvy, Marie</creator><creator>Pétorin, Caroline</creator><creator>Gagnière, Johan</creator><creator>Futier, Emmanuel</creator><creator>Slim, Karem</creator><creator>Meunier, Bernard</creator><creator>Mabrut, Jean-Yves</creator><creator>Mariette, Christophe</creator><creator>Pezet, Denis</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-4668-9275</orcidid><orcidid>https://orcid.org/0000-0003-3778-7161</orcidid><orcidid>https://orcid.org/0000-0002-6454-271X</orcidid></search><sort><creationdate>20161207</creationdate><title>Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial—the PREHAB study</title><author>Le Roy, Bertrand ; Pereira, Bruno ; Bouteloup, Corinne ; Costes, Frédéric ; Richard, Ruddy ; Selvy, Marie ; Pétorin, Caroline ; Gagnière, Johan ; Futier, Emmanuel ; Slim, Karem ; Meunier, Bernard ; Mabrut, Jean-Yves ; Mariette, Christophe ; Pezet, Denis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b506t-1e943be3b5d178f187bdaac23192a1294240b4e277dd71a3b0daef28ad60246b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adenocarcinoma - complications</topic><topic>Adenocarcinoma - physiopathology</topic><topic>Adenocarcinoma - therapy</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Anxiety</topic><topic>Chemotherapy</topic><topic>Clinical trials</topic><topic>Compliance</topic><topic>Consent</topic><topic>Esophageal cancer</topic><topic>Esophageal Neoplasms - complications</topic><topic>Esophageal Neoplasms - physiopathology</topic><topic>Esophageal Neoplasms - therapy</topic><topic>Exercise</topic><topic>Female</topic><topic>Food and Nutrition</topic><topic>France</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Intervention</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Morbidity</topic><topic>Mortality</topic><topic>Nutrition</topic><topic>Nutrition Therapy</topic><topic>Nutritional status</topic><topic>Nutritionists</topic><topic>Patients</topic><topic>Physical fitness</topic><topic>Physical therapists</topic><topic>Postoperative Complications - prevention & control</topic><topic>Preoperative Care - methods</topic><topic>Prospective Studies</topic><topic>Proteins</topic><topic>Psychologists</topic><topic>Quality of Life</topic><topic>Stomach Neoplasms - complications</topic><topic>Stomach Neoplasms - physiopathology</topic><topic>Stomach Neoplasms - therapy</topic><topic>Surgeons</topic><topic>Surgery</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Le Roy, Bertrand</creatorcontrib><creatorcontrib>Pereira, Bruno</creatorcontrib><creatorcontrib>Bouteloup, Corinne</creatorcontrib><creatorcontrib>Costes, Frédéric</creatorcontrib><creatorcontrib>Richard, Ruddy</creatorcontrib><creatorcontrib>Selvy, Marie</creatorcontrib><creatorcontrib>Pétorin, Caroline</creatorcontrib><creatorcontrib>Gagnière, Johan</creatorcontrib><creatorcontrib>Futier, Emmanuel</creatorcontrib><creatorcontrib>Slim, Karem</creatorcontrib><creatorcontrib>Meunier, Bernard</creatorcontrib><creatorcontrib>Mabrut, Jean-Yves</creatorcontrib><creatorcontrib>Mariette, Christophe</creatorcontrib><creatorcontrib>Pezet, Denis</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Le Roy, Bertrand</au><au>Pereira, Bruno</au><au>Bouteloup, Corinne</au><au>Costes, Frédéric</au><au>Richard, Ruddy</au><au>Selvy, Marie</au><au>Pétorin, Caroline</au><au>Gagnière, Johan</au><au>Futier, Emmanuel</au><au>Slim, Karem</au><au>Meunier, Bernard</au><au>Mabrut, Jean-Yves</au><au>Mariette, Christophe</au><au>Pezet, Denis</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial—the PREHAB study</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2016-12-07</date><risdate>2016</risdate><volume>6</volume><issue>12</issue><spage>e012876</spage><epage>e012876</epage><pages>e012876-e012876</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionPerioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based on 3 components: (1) physical management, (2) nutritional care and (3) psychological care. Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment.Methods and analysisThe PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy. This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. Patients (n=60 per group) will be randomly assigned for management with either prehabilitation or conventional care. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, overall survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy (defined by the VO2peak, ventilatory threshold and 6-min walk test), preoperative and postoperative nutritional status, preoperative anxiety, quality of life, 30-day and 90-day mortality and cumulative dose of cytotoxic treatment received.Ethics and disseminationThe study was approved by an independent medical ethics committee (IRB00008526, CPP Sud-Est VI, Clermont-Ferrand, France) and by the competent French authority (ANSM, Saint Denis, France) and registered on Clinicaltrial.gov. The results will be disseminated in a peer-reviewed journal.Trial registration numberNCT02780921.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>27927660</pmid><doi>10.1136/bmjopen-2016-012876</doi><orcidid>https://orcid.org/0000-0002-4668-9275</orcidid><orcidid>https://orcid.org/0000-0003-3778-7161</orcidid><orcidid>https://orcid.org/0000-0002-6454-271X</orcidid><oa>free_for_read</oa></addata></record> |
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| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5168676 |
| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access |
| subjects | Adenocarcinoma - complications Adenocarcinoma - physiopathology Adenocarcinoma - therapy Aged Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Anxiety Chemotherapy Clinical trials Compliance Consent Esophageal cancer Esophageal Neoplasms - complications Esophageal Neoplasms - physiopathology Esophageal Neoplasms - therapy Exercise Female Food and Nutrition France Human health and pathology Humans Intervention Life Sciences Male Middle Aged Morbidity Mortality Nutrition Nutrition Therapy Nutritional status Nutritionists Patients Physical fitness Physical therapists Postoperative Complications - prevention & control Preoperative Care - methods Prospective Studies Proteins Psychologists Quality of Life Stomach Neoplasms - complications Stomach Neoplasms - physiopathology Stomach Neoplasms - therapy Surgeons Surgery Treatment Outcome |
| title | Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial—the PREHAB study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-05T02%3A39%3A58IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effect%20of%20prehabilitation%20in%20gastro-oesophageal%20adenocarcinoma:%20study%20protocol%20of%20a%20multicentric,%20randomised,%20control%20trial%E2%80%94the%20PREHAB%20study&rft.jtitle=BMJ%20open&rft.au=Le%20Roy,%20Bertrand&rft.date=2016-12-07&rft.volume=6&rft.issue=12&rft.spage=e012876&rft.epage=e012876&rft.pages=e012876-e012876&rft.issn=2044-6055&rft.eissn=2044-6055&rft_id=info:doi/10.1136/bmjopen-2016-012876&rft_dat=%3Cproquest_pubme%3E4272025281%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1846650613&rft_id=info:pmid/27927660&rfr_iscdi=true |