Evolution of Physical Status From Diagnosis to the End of First-Line Treatment in Breast, Lung, and Colorectal Cancer Patients: The PROTECT-01 Cohort Study Protocol
Background: Cancer cachexia and exacerbated fatigue represent two hallmarks in cancer patients, negatively impacting their exercise tolerance and ultimately their quality of life. However, the characterization of patients' physical status and exercise tolerance and, most importantly, their evol...
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| Vydáno v: | Frontiers in oncology Ročník 10; s. 1304 |
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Frontiers Media S.A
07.08.2020
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| ISSN: | 2234-943X, 2234-943X |
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| Abstract | Background: Cancer cachexia and exacerbated fatigue represent two hallmarks in cancer patients, negatively impacting their exercise tolerance and ultimately their quality of life. However, the characterization of patients' physical status and exercise tolerance and, most importantly, their evolution throughout cancer treatment may represent the first step in efficiently counteracting their development with prescribed and tailored exercise training. In this context, the aim of the PROTECT-01 study will be to investigate the evolution of physical status, from diagnosis to the end of first-line treatment, of patients with one of the three most common cancers (i.e., lung, breast, and colorectal). Methods: The PROTECT-01 cohort study will include 300 patients equally divided between lung, breast and colorectal cancer. Patients will perform a series of assessments at three visits throughout the treatment: (1) between the date of diagnosis and the start of treatment, (2) 8 weeks after the start of treatment, and (3) after the completion of first-line treatment or at the 6-months mark, whichever occurs first. For each of the three visits, subjective and objective fatigue, maximal voluntary force, body composition, cachexia, physical activity level, quality of life, respiratory function, overall physical performance, and exercise tolerance will be assessed. Discussion: The present study is aimed at identifying the nature and severity of maladaptation related to exercise intolerance in the three most common cancers. Therefore, our results should contribute to the delineation of the needs of each group of patients and to the determination of the most valuable exercise interventions in order to counteract these maladaptations. This descriptive and comprehensive approach is a prerequisite in order to elaborate, through future interventional research projects, tailored exercise strategies to counteract specific symptoms that are potentially cancer type-dependent and, in fine, to improve the health and quality of life of cancer patients. Moreover, our concomitant focus on fatigue and cachexia will provide insightful information about two factors that may have substantial interaction but require further investigation. Trial registration: This prospective study has been registered at ClinicalTrials.gov (NCT03956641), May, 2019.Background: Cancer cachexia and exacerbated fatigue represent two hallmarks in cancer patients, negatively impacting their exercise tolerance and ultimately their quality of life. However, the characterization of patients' physical status and exercise tolerance and, most importantly, their evolution throughout cancer treatment may represent the first step in efficiently counteracting their development with prescribed and tailored exercise training. In this context, the aim of the PROTECT-01 study will be to investigate the evolution of physical status, from diagnosis to the end of first-line treatment, of patients with one of the three most common cancers (i.e., lung, breast, and colorectal). Methods: The PROTECT-01 cohort study will include 300 patients equally divided between lung, breast and colorectal cancer. Patients will perform a series of assessments at three visits throughout the treatment: (1) between the date of diagnosis and the start of treatment, (2) 8 weeks after the start of treatment, and (3) after the completion of first-line treatment or at the 6-months mark, whichever occurs first. For each of the three visits, subjective and objective fatigue, maximal voluntary force, body composition, cachexia, physical activity level, quality of life, respiratory function, overall physical performance, and exercise tolerance will be assessed. Discussion: The present study is aimed at identifying the nature and severity of maladaptation related to exercise intolerance in the three most common cancers. Therefore, our results should contribute to the delineation of the needs of each group of patients and to the determination of the most valuable exercise interventions in order to counteract these maladaptations. This descriptive and comprehensive approach is a prerequisite in order to elaborate, through future interventional research projects, tailored exercise strategies to counteract specific symptoms that are potentially cancer type-dependent and, in fine, to improve the health and quality of life of cancer patients. Moreover, our concomitant focus on fatigue and cachexia will provide insightful information about two factors that may have substantial interaction but require further investigation. Trial registration: This prospective study has been registered at ClinicalTrials.gov (NCT03956641), May, 2019. |
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| AbstractList | Background: Cancer cachexia and exacerbated fatigue represent two hallmarks in cancer patients, negatively impacting their exercise tolerance and ultimately their quality of life. However, the characterization of patients' physical status and exercise tolerance and, most importantly, their evolution throughout cancer treatment may represent the first step in efficiently counteracting their development with prescribed and tailored exercise training. In this context, the aim of the PROTECT-01 study will be to investigate the evolution of physical status, from diagnosis to the end of first-line treatment, of patients with one of the three most common cancers (i.e., lung, breast, and colorectal). Methods: The PROTECT-01 cohort study will include 300 patients equally divided between lung, breast and colorectal cancer. Patients will perform a series of assessments at three visits throughout the treatment: (1) between the date of diagnosis and the start of treatment, (2) 8 weeks after the start of treatment, and (3) after the completion of first-line treatment or at the 6-months mark, whichever occurs first. For each of the three visits, subjective and objective fatigue, maximal voluntary force, body composition, cachexia, physical activity level, quality of life, respiratory function, overall physical performance, and exercise tolerance will be assessed. Discussion: The present study is aimed at identifying the nature and severity of maladaptation related to exercise intolerance in the three most common cancers. Therefore, our results should contribute to the delineation of the needs of each group of patients and to the determination of the most valuable exercise interventions in order to counteract these maladaptations. This descriptive and comprehensive approach is a prerequisite in order to elaborate, through future interventional research projects, tailored exercise strategies to counteract specific symptoms that are potentially cancer type-dependent and, in fine, to improve the health and quality of life of cancer patients. Moreover, our concomitant focus on fatigue and cachexia will provide insightful information about two factors that may have substantial interaction but require further investigation. Trial registration: This prospective study has been registered at ClinicalTrials.gov (NCT03956641), May, 2019. Background: Cancer cachexia and exacerbated fatigue represent two hallmarks in cancer patients, negatively impacting their exercise tolerance and ultimately their quality of life. However, the characterization of patients' physical status and exercise tolerance and, most importantly, their evolution throughout cancer treatment may represent the first step in efficiently counteracting their development with prescribed and tailored exercise training. In this context, the aim of the PROTECT-01 study will be to investigate the evolution of physical status, from diagnosis to the end of first-line treatment, of patients with one of the three most common cancers (i.e., lung, breast, and colorectal). Methods: The PROTECT-01 cohort study will include 300 patients equally divided between lung, breast and colorectal cancer. Patients will perform a series of assessments at three visits throughout the treatment: (1) between the date of diagnosis and the start of treatment, (2) 8 weeks after the start of treatment, and (3) after the completion of first-line treatment or at the 6-months mark, whichever occurs first. For each of the three visits, subjective and objective fatigue, maximal voluntary force, body composition, cachexia, physical activity level, quality of life, respiratory function, overall physical performance, and exercise tolerance will be assessed. Discussion: The present study is aimed at identifying the nature and severity of maladaptation related to exercise intolerance in the three most common cancers. Therefore, our results should contribute to the delineation of the needs of each group of patients and to the determination of the most valuable exercise interventions in order to counteract these maladaptations. This descriptive and comprehensive approach is a prerequisite in order to elaborate, through future interventional research projects, tailored exercise strategies to counteract specific symptoms that are potentially cancer type-dependent and, in fine, to improve the health and quality of life of cancer patients. Moreover, our concomitant focus on fatigue and cachexia will provide insightful information about two factors that may have substantial interaction but require further investigation. Trial registration: This prospective study has been registered at ClinicalTrials.gov (NCT03956641), May, 2019.Background: Cancer cachexia and exacerbated fatigue represent two hallmarks in cancer patients, negatively impacting their exercise tolerance and ultimately their quality of life. However, the characterization of patients' physical status and exercise tolerance and, most importantly, their evolution throughout cancer treatment may represent the first step in efficiently counteracting their development with prescribed and tailored exercise training. In this context, the aim of the PROTECT-01 study will be to investigate the evolution of physical status, from diagnosis to the end of first-line treatment, of patients with one of the three most common cancers (i.e., lung, breast, and colorectal). Methods: The PROTECT-01 cohort study will include 300 patients equally divided between lung, breast and colorectal cancer. Patients will perform a series of assessments at three visits throughout the treatment: (1) between the date of diagnosis and the start of treatment, (2) 8 weeks after the start of treatment, and (3) after the completion of first-line treatment or at the 6-months mark, whichever occurs first. For each of the three visits, subjective and objective fatigue, maximal voluntary force, body composition, cachexia, physical activity level, quality of life, respiratory function, overall physical performance, and exercise tolerance will be assessed. Discussion: The present study is aimed at identifying the nature and severity of maladaptation related to exercise intolerance in the three most common cancers. Therefore, our results should contribute to the delineation of the needs of each group of patients and to the determination of the most valuable exercise interventions in order to counteract these maladaptations. This descriptive and comprehensive approach is a prerequisite in order to elaborate, through future interventional research projects, tailored exercise strategies to counteract specific symptoms that are potentially cancer type-dependent and, in fine, to improve the health and quality of life of cancer patients. Moreover, our concomitant focus on fatigue and cachexia will provide insightful information about two factors that may have substantial interaction but require further investigation. Trial registration: This prospective study has been registered at ClinicalTrials.gov (NCT03956641), May, 2019. |
| Author | Ben Abdelghani, Meher Hucteau, Elyse Kalish-Weindling, Michal Belletier, Christine Carinato, Hélène Fischbach, Cathie Chiappa, Pascale Favret, Fabrice Dufour, Stéphane Pagano, Allan F. Demarchi, Martin Pivot, Xavier Schott, Roland Mallard, Joris Petit, Thierry Bousinière, Audren Hureau, Thomas J. |
| AuthorAffiliation | 2 EA 3072: Mitochondria, Oxidative Stress and Muscular Protection Laboratory, Faculty of Medicine, Faculty of Sports Sciences, University of Strasbourg , Strasbourg , France 1 Institut de Cancérologie Strasbourg Europe (ICANS) , Strasbourg , France |
| AuthorAffiliation_xml | – name: 2 EA 3072: Mitochondria, Oxidative Stress and Muscular Protection Laboratory, Faculty of Medicine, Faculty of Sports Sciences, University of Strasbourg , Strasbourg , France – name: 1 Institut de Cancérologie Strasbourg Europe (ICANS) , Strasbourg , France |
| Author_xml | – sequence: 1 givenname: Joris surname: Mallard fullname: Mallard, Joris – sequence: 2 givenname: Elyse surname: Hucteau fullname: Hucteau, Elyse – sequence: 3 givenname: Roland surname: Schott fullname: Schott, Roland – sequence: 4 givenname: Thierry surname: Petit fullname: Petit, Thierry – sequence: 5 givenname: Martin surname: Demarchi fullname: Demarchi, Martin – sequence: 6 givenname: Christine surname: Belletier fullname: Belletier, Christine – sequence: 7 givenname: Meher surname: Ben Abdelghani fullname: Ben Abdelghani, Meher – sequence: 8 givenname: Hélène surname: Carinato fullname: Carinato, Hélène – sequence: 9 givenname: Pascale surname: Chiappa fullname: Chiappa, Pascale – sequence: 10 givenname: Cathie surname: Fischbach fullname: Fischbach, Cathie – sequence: 11 givenname: Michal surname: Kalish-Weindling fullname: Kalish-Weindling, Michal – sequence: 12 givenname: Audren surname: Bousinière fullname: Bousinière, Audren – sequence: 13 givenname: Stéphane surname: Dufour fullname: Dufour, Stéphane – sequence: 14 givenname: Fabrice surname: Favret fullname: Favret, Fabrice – sequence: 15 givenname: Xavier surname: Pivot fullname: Pivot, Xavier – sequence: 16 givenname: Thomas J. surname: Hureau fullname: Hureau, Thomas J. – sequence: 17 givenname: Allan F. surname: Pagano fullname: Pagano, Allan F. |
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| Cites_doi | 10.1113/JP273895 10.1093/annonc/mdt551 10.1007/s13539-013-0105-y 10.1016/S0885-3924(00)00258-X 10.1136/bjsports-2013-093080 10.1016/j.ejso.2016.02.094 10.1038/ejcn.2012.160 10.1080/00016489.2019.1566779 10.1038/sj.bjc.6602012 10.7861/clinmedicine.6-2-140 10.1016/S1470-2045(03)01221-X 10.1016/j.lungcan.2011.10.009 10.1016/j.pmrj.2017.07.074 10.3322/caac.21492 10.1200/JCO.2001.19.14.3385 10.1200/JCO.2014.56.1894 10.3390/nu9070695 10.1249/MSS.0b013e3181e0c112 10.2217/fon.15.195 10.1080/09638288.2016.1260647 10.1093/gerona/55.4.M221 10.1177/0898264312438551 10.1002/jcsm.12206 10.1007/s13539-012-0096-0 10.1093/jnci/85.5.365 10.1093/annonc/mdr447 10.3389/fnut.2019.00075 10.1016/j.neuroimage.2011.11.038 10.1177/1559827617725283 10.1001/jamaoncol.2016.1867 10.1016/j.critrevonc.2013.07.001 10.1016/j.mam.2016.04.006 10.1007/s10389-006-0024-x 10.1002/cncr.28382 10.1249/MSS.0000000000000929 10.1007/s11764-015-0450-2 10.1634/theoncologist.12-S1-22 10.1249/MSS.0000000000000975 10.1186/s12885-018-4668-z 10.3389/fphys.2018.01819 10.1097/MD.0000000000011068 10.1016/j.ctrv.2016.11.010 10.1016/S0140-6736(03)14186-4 10.1111/j.1582-4934.2009.00864.x 10.1016/j.jpsychores.2012.10.011 10.1093/oxfordjournals.jncimonographs.a003451 10.1016/j.jpainsymman.2011.06.013 10.1016/S1470-2045(10)70218-7 10.1249/JSR.0b013e3181c22324 10.1152/physrev.2001.81.4.1725 10.1634/theoncologist.5-5-353 10.1016/j.bbrc.2013.05.018 10.1177/1479972315575715 10.1164/ajrccm.166.1.at1102 10.1007/s13539-010-0016-0 10.1093/oxfordjournals.eurheartj.a014971 10.4103/0253-7176.116232 10.1016/j.clnu.2008.06.013 10.1007/s00520-018-4320-0 10.1002/jcsm.12199 10.1016/j.rmed.2005.08.003 10.1067/mhj.2001.118468 10.1186/s12885-017-3687-5 10.1016/j.jsams.2019.05.003 10.1001/jamaoncol.2015.2378 10.1001/jamaoncol.2016.6914 10.1158/1055-9965.EPI-10-0988 10.1016/j.biocel.2013.06.011 10.1200/JCO.2012.41.6222 10.1093/epirev/mxx007 10.1136/ijgc-00009577-200209000-00002 10.5539/cco.v4n1p19 10.1016/S1470-2045(09)70031-2 10.1002/jcsm.12043 10.1093/annonc/mdw099 10.1038/sj.bjc.6605578 10.7573/dic.212265 10.1002/14651858.CD006145.pub2 10.1038/nrdp.2017.105 10.3390/jfmk2010004 10.1093/jnci/djy218 |
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| Copyright | Copyright © 2020 Mallard, Hucteau, Schott, Petit, Demarchi, Belletier, Ben Abdelghani, Carinato, Chiappa, Fischbach, Kalish-Weindling, Bousinière, Dufour, Favret, Pivot, Hureau and Pagano. Copyright © 2020 Mallard, Hucteau, Schott, Petit, Demarchi, Belletier, Ben Abdelghani, Carinato, Chiappa, Fischbach, Kalish-Weindling, Bousinière, Dufour, Favret, Pivot, Hureau and Pagano. 2020 Mallard, Hucteau, Schott, Petit, Demarchi, Belletier, Ben Abdelghani, Carinato, Chiappa, Fischbach, Kalish-Weindling, Bousinière, Dufour, Favret, Pivot, Hureau and Pagano |
| Copyright_xml | – notice: Copyright © 2020 Mallard, Hucteau, Schott, Petit, Demarchi, Belletier, Ben Abdelghani, Carinato, Chiappa, Fischbach, Kalish-Weindling, Bousinière, Dufour, Favret, Pivot, Hureau and Pagano. – notice: Copyright © 2020 Mallard, Hucteau, Schott, Petit, Demarchi, Belletier, Ben Abdelghani, Carinato, Chiappa, Fischbach, Kalish-Weindling, Bousinière, Dufour, Favret, Pivot, Hureau and Pagano. 2020 Mallard, Hucteau, Schott, Petit, Demarchi, Belletier, Ben Abdelghani, Carinato, Chiappa, Fischbach, Kalish-Weindling, Bousinière, Dufour, Favret, Pivot, Hureau and Pagano |
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| Notes | ObjectType-Case Study-2 SourceType-Scholarly Journals-1 ObjectType-Feature-4 content type line 23 ObjectType-Report-1 ObjectType-Article-3 Edited by: Yun Dai, Peking University First Hospital, China These authors have contributed equally to this work This article was submitted to Gastrointestinal Cancers, a section of the journal Frontiers in Oncology Reviewed by: Antonio Macciò, Ospedale Oncologico Armando Businco, Italy; Moritz Schumann, German Sport University Cologne, Germany |
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| Title | Evolution of Physical Status From Diagnosis to the End of First-Line Treatment in Breast, Lung, and Colorectal Cancer Patients: The PROTECT-01 Cohort Study Protocol |
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