Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study
Identifieur interne : 003236 ( Main/Exploration ); précédent : 003235; suivant : 003237Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study
Auteurs : Karin Potthoff [Allemagne] ; Martina E. Schmidt [Allemagne] ; Joachim Wiskemann [Allemagne] ; Holger Hof [Allemagne] ; Oliver Klassen [Allemagne] ; Nina Habermann [Allemagne] ; Philipp Beckhove [Allemagne] ; Juergen Debus [Allemagne] ; Cornelia M. Ulrich [Allemagne] ; Karen Steindorf [Allemagne]Source :
- BMC Cancer [ 1471-2407 ] ; 2013.
Abstract
Cancer-related fatigue (CRF) is one of the most common and distressing side effects of cancer and its treatment. During and after radiotherapy breast cancer patients often suffer from CRF which frequently impairs quality of life (QoL). Despite the high prevalence of CRF in breast cancer patients and the severe impact on the physical and emotional well-being, effective treatment methods are scarce.
Physical activity for breast cancer patients has been reported to decrease fatigue, to improve emotional well-being and to increase physical strength. The pathophysiological and molecular mechanisms of CRF and the molecular-biologic changes induced by exercise, however, are poorly understood.
In the BEST trial we aim to assess the effects of resistance training on fatigue, QoL and physical fitness as well as on molecular, immunological and inflammatory changes in breast cancer patients during adjuvant radiotherapy.
The BEST study is a prospective randomized, controlled intervention trial investigating the effects of a 12-week supervised progressive resistance training compared to a 12-week supervised muscle relaxation training in 160 patients with breast cancer undergoing adjuvant radiotherapy. To determine the effect of exercise itself beyond potential psychosocial group effects, patients in the control group perform a group-based progressive muscle relaxation training. Main inclusion criterion is histologically confirmed breast cancer stage I-III after lumpectomy or mastectomy with indication for adjuvant radiotherapy. Main exclusion criteria are acute infectious diseases, severe neurological, musculosceletal or cardiorespiratory disorders. The primary endpoint is cancer-related fatigue; secondary endpoints include immunological and inflammatory parameters analyzed in peripheral blood, saliva and urine. In addition, QoL, depression, physical performance and cognitive capacity will be assessed.
The BEST study is the first randomized controlled trial comparing progressive resistance training with muscle relaxation training in breast cancer patients during adjuvant radiotherapy. Based on the analysis of physiological, immunological and inflammatory parameters it will contribute to a better understanding of the physiological and psychosocial effects and the biological mechanisms of resistance training. The ultimate goal is the implementation of optimized intervention programs to reduce fatigue, improve quality of life and potentially the prognosis after breast cancer.
ClinicalTrials.gov
Url:
DOI: 10.1186/1471-2407-13-162
PubMed: 23537231
PubMed Central: 3617011
Affiliations:
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Schmidt</name><affiliation wicri:level="3"><nlm:aff id="I2">Unit of Physical Activity and Cancer, German Cancer Research Center, Im Neuenheimer Feld 280, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Unit of Physical Activity and Cancer, German Cancer Research Center, Im Neuenheimer Feld 280, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Wiskemann, Joachim" sort="Wiskemann, Joachim" uniqKey="Wiskemann J" first="Joachim" last="Wiskemann">Joachim Wiskemann</name><affiliation wicri:level="3"><nlm:aff id="I3">Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="I4">Department of Medical Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Medical Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Hof, Holger" sort="Hof, Holger" uniqKey="Hof H" first="Holger" last="Hof">Holger Hof</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Radiation Oncology, University of Heidelberg Medical Center, Im Neuenheimer Feld 400, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Radiation Oncology, University of Heidelberg Medical Center, Im Neuenheimer Feld 400, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Klassen, Oliver" sort="Klassen, Oliver" uniqKey="Klassen O" first="Oliver" last="Klassen">Oliver Klassen</name><affiliation wicri:level="3"><nlm:aff id="I3">Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Habermann, Nina" sort="Habermann, Nina" uniqKey="Habermann N" first="Nina" last="Habermann">Nina Habermann</name><affiliation wicri:level="3"><nlm:aff id="I3">Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Beckhove, Philipp" sort="Beckhove, Philipp" uniqKey="Beckhove P" first="Philipp" last="Beckhove">Philipp Beckhove</name><affiliation wicri:level="3"><nlm:aff id="I5">Division of Translational Immunology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Division of Translational Immunology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Debus, Juergen" sort="Debus, Juergen" uniqKey="Debus J" first="Juergen" last="Debus">Juergen Debus</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Radiation Oncology, University of Heidelberg Medical Center, Im Neuenheimer Feld 400, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Radiation Oncology, University of Heidelberg Medical Center, Im Neuenheimer Feld 400, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Ulrich, Cornelia M" sort="Ulrich, Cornelia M" uniqKey="Ulrich C" first="Cornelia M" last="Ulrich">Cornelia M. Ulrich</name><affiliation wicri:level="3"><nlm:aff id="I3">Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Steindorf, Karen" sort="Steindorf, Karen" uniqKey="Steindorf K" first="Karen" last="Steindorf">Karen Steindorf</name><affiliation wicri:level="3"><nlm:aff id="I2">Unit of Physical Activity and Cancer, German Cancer Research Center, Im Neuenheimer Feld 280, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Unit of Physical Activity and Cancer, German Cancer Research Center, Im Neuenheimer Feld 280, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="I3">Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Preventive Oncology, National Center for Tumor Diseases, Im Neuenheimer Feld 460, Heidelberg 69120</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Cancer-related fatigue (CRF) is one of the most common and distressing side effects of cancer and its treatment. During and after radiotherapy breast cancer patients often suffer from CRF which frequently impairs quality of life (QoL). Despite the high prevalence of CRF in breast cancer patients and the severe impact on the physical and emotional well-being, effective treatment methods are scarce.</p><p>Physical activity for breast cancer patients has been reported to decrease fatigue, to improve emotional well-being and to increase physical strength. The pathophysiological and molecular mechanisms of CRF and the molecular-biologic changes induced by exercise, however, are poorly understood.</p><p>In the BEST trial we aim to assess the effects of resistance training on fatigue, QoL and physical fitness as well as on molecular, immunological and inflammatory changes in breast cancer patients during adjuvant radiotherapy.</p></sec><sec><title>Methods/design</title><p>The BEST study is a prospective randomized, controlled intervention trial investigating the effects of a 12-week supervised progressive resistance training compared to a 12-week supervised muscle relaxation training in 160 patients with breast cancer undergoing adjuvant radiotherapy. To determine the effect of exercise itself beyond potential psychosocial group effects, patients in the control group perform a group-based progressive muscle relaxation training. Main inclusion criterion is histologically confirmed breast cancer stage I-III after lumpectomy or mastectomy with indication for adjuvant radiotherapy. Main exclusion criteria are acute infectious diseases, severe neurological, musculosceletal or cardiorespiratory disorders. The primary endpoint is cancer-related fatigue; secondary endpoints include immunological and inflammatory parameters analyzed in peripheral blood, saliva and urine. In addition, QoL, depression, physical performance and cognitive capacity will be assessed.</p></sec><sec><title>Discussion</title><p>The BEST study is the first randomized controlled trial comparing progressive resistance training with muscle relaxation training in breast cancer patients during adjuvant radiotherapy. Based on the analysis of physiological, immunological and inflammatory parameters it will contribute to a better understanding of the physiological and psychosocial effects and the biological mechanisms of resistance training. The ultimate goal is the implementation of optimized intervention programs to reduce fatigue, improve quality of life and potentially the prognosis after breast cancer.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov/ct2/show/NCT01468766?term=NCT01468766&rank=1">NCT01468766</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Darby, S" uniqKey="Darby S">S Darby</name></author><author><name sortKey="Mcgale, P" uniqKey="Mcgale P">P McGale</name></author><author><name sortKey="Correa, C" uniqKey="Correa C">C Correa</name></author><author><name sortKey="Taylor, C" uniqKey="Taylor C">C Taylor</name></author><author><name sortKey="Arriagada, R" uniqKey="Arriagada R">R Arriagada</name></author><author><name sortKey="Clarke, M" uniqKey="Clarke M">M Clarke</name></author><author><name sortKey="Cutter, D" uniqKey="Cutter D">D 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Holger" sort="Hof, Holger" uniqKey="Hof H" first="Holger" last="Hof">Holger Hof</name><name sortKey="Klassen, Oliver" sort="Klassen, Oliver" uniqKey="Klassen O" first="Oliver" last="Klassen">Oliver Klassen</name><name sortKey="Potthoff, Karin" sort="Potthoff, Karin" uniqKey="Potthoff K" first="Karin" last="Potthoff">Karin Potthoff</name><name sortKey="Schmidt, Martina E" sort="Schmidt, Martina E" uniqKey="Schmidt M" first="Martina E" last="Schmidt">Martina E. Schmidt</name><name sortKey="Steindorf, Karen" sort="Steindorf, Karen" uniqKey="Steindorf K" first="Karen" last="Steindorf">Karen Steindorf</name><name sortKey="Steindorf, Karen" sort="Steindorf, Karen" uniqKey="Steindorf K" first="Karen" last="Steindorf">Karen Steindorf</name><name sortKey="Ulrich, Cornelia M" sort="Ulrich, Cornelia M" uniqKey="Ulrich C" first="Cornelia M" last="Ulrich">Cornelia M. Ulrich</name><name sortKey="Wiskemann, Joachim" sort="Wiskemann, Joachim" uniqKey="Wiskemann J" first="Joachim" last="Wiskemann">Joachim Wiskemann</name><name sortKey="Wiskemann, Joachim" sort="Wiskemann, Joachim" uniqKey="Wiskemann J" first="Joachim" last="Wiskemann">Joachim Wiskemann</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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