Abstract：
BACKGROUND: (Neo-)adjuvant chemotherapy for breast cancer is effective but has deleterious side effects on muscle tissue, resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side effects. However, no study has compared the effect of high-intensity training versus low-to-moderate intensity training on muscle tissue cellular outcomes and physical function in patients with breast cancer during chemotherapy.
OBJECTIVE: The aim of this substudy within the Physical Training in Cancer (Phys-Can) consortium is to evaluate and compare the effects of high and low-to-moderate intensity exercise on muscle cellular outcomes, muscle function, and cardiorespiratory fitness in women with breast cancer undergoing (neo-)adjuvant chemotherapy. We further aim to investigate if the effects of chemotherapy including taxanes on muscles will be different from those of taxane-free chemotherapy.
METHODS: Eighty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to a combination of strength and endurance training, either at high intensity or at low-to-moderate intensity. Testing of muscle function and cardiorespiratory fitness and collection of muscle biopsies from the vastus lateralis muscle will be performed before the first cycle of chemotherapy (or after 1 week, when not possible) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50% of the participants will be willing to undergo muscle biopsies. To separate the effect of the treatment itself, a usual care group with no supervised training will also be included, and in this group, testing and collection of muscle biopsies will be performed at T0 and T2 only.
RESULTS: This study is funded by Active Against Cancer (Aktiv mot kreft) (May 2013) and the Norwegian Cancer Society (December 2018). Inclusion started in December 2016 and the last participant is expected to be recruited in December 2022. As of June 2022, we enrolled 38 (19 with biopsies) participants to the high-intensity training group, 36 (19 with biopsies) participants to the low-to-moderate intensity training group, and 17 (16 with biopsies) participants to the usual care group. Data analyses will start in fall 2022. The first results are expected to be published in spring 2024.
CONCLUSIONS: This study will generate new knowledge about the effects of different training intensities for women with breast cancer during chemotherapy treatment. It will give further insight into how chemotherapy affects the muscle tissue and how physical training at different intensities may counteract the treatment side effects in muscles. The results of this study will inform the development and refinement of exercise programs that are effective and compatible with the multidisciplinary management of breast cancer.
BACKGROUND: ClinicalTrials.gov NCT05218876; https://tinyurl.com/ysaj9dhm.
UNASSIGNED: DERR1-10.2196/40811.
OBJECTIVE: The aim of this substudy within the Physical Training in Cancer (Phys-Can) consortium is to evaluate and compare the effects of high and low-to-moderate intensity exercise on muscle cellular outcomes, muscle function, and cardiorespiratory fitness in women with breast cancer undergoing (neo-)adjuvant chemotherapy. We further aim to investigate if the effects of chemotherapy including taxanes on muscles will be different from those of taxane-free chemotherapy.
METHODS: Eighty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to a combination of strength and endurance training, either at high intensity or at low-to-moderate intensity. Testing of muscle function and cardiorespiratory fitness and collection of muscle biopsies from the vastus lateralis muscle will be performed before the first cycle of chemotherapy (or after 1 week, when not possible) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50% of the participants will be willing to undergo muscle biopsies. To separate the effect of the treatment itself, a usual care group with no supervised training will also be included, and in this group, testing and collection of muscle biopsies will be performed at T0 and T2 only.
RESULTS: This study is funded by Active Against Cancer (Aktiv mot kreft) (May 2013) and the Norwegian Cancer Society (December 2018). Inclusion started in December 2016 and the last participant is expected to be recruited in December 2022. As of June 2022, we enrolled 38 (19 with biopsies) participants to the high-intensity training group, 36 (19 with biopsies) participants to the low-to-moderate intensity training group, and 17 (16 with biopsies) participants to the usual care group. Data analyses will start in fall 2022. The first results are expected to be published in spring 2024.
CONCLUSIONS: This study will generate new knowledge about the effects of different training intensities for women with breast cancer during chemotherapy treatment. It will give further insight into how chemotherapy affects the muscle tissue and how physical training at different intensities may counteract the treatment side effects in muscles. The results of this study will inform the development and refinement of exercise programs that are effective and compatible with the multidisciplinary management of breast cancer.
BACKGROUND: ClinicalTrials.gov NCT05218876; https://tinyurl.com/ysaj9dhm.
UNASSIGNED: DERR1-10.2196/40811.
摘要：
背景：（Neo-）乳腺癌辅助化疗是有效的，但对肌肉组织有有害的副作用，导致骨骼肌质量减少，肌肉功能，和心肺健康。癌症治疗期间的各种运动方案已被证明可以抵消这些副作用中的一些。然而,没有研究比较高强度训练与中低强度训练对乳腺癌患者化疗期间肌肉组织细胞结局和身体功能的影响.
目的：癌症体育锻炼（Phys-Can）联盟的这项子研究的目的是评估和比较高强度和低强度至中等强度运动对肌肉细胞结果的影响。肌肉功能，以及接受（新）辅助化疗的乳腺癌女性的心肺适应性。我们进一步旨在研究包括紫杉烷类药物在内的化疗对肌肉的影响是否与无紫杉烷的化疗不同。
方法：80名最近被诊断为乳腺癌的女性，计划开始（新）辅助化疗，将被随机分配到力量和耐力训练的组合，高强度或低至中等强度。在第一个化疗周期之前（或1周后，当不可能时)(T0)，化疗中途（T1），和完成化疗后（T2）。据估计，大约50％的参与者愿意接受肌肉活检。为了分离治疗本身的效果，一个没有监督培训的常规护理小组也将包括在内，在这个群体中，仅在T0和T2进行肌肉活检的测试和收集。
结果：这项研究由积极抗癌（Aktivmotkreft）（2013年5月）和挪威癌症协会（2018年12月）资助。纳入计划于2016年12月开始，预计最后一名参与者将于2022年12月招募。截至2022年6月，我们招募了38名（19名活检）参与者加入高强度训练组，36名（19名活检）参与者参加了中低强度训练组，17名（16名活检）参与者进入常规护理组。数据分析将于2022年秋季开始。第一个结果预计将于2024年春季发布。
结论：本研究将为乳腺癌患者化疗期间不同训练强度的影响提供新的知识。它将进一步深入了解化疗如何影响肌肉组织，以及不同强度的体育锻炼如何抵消肌肉的治疗副作用。这项研究的结果将为有效且与乳腺癌多学科管理兼容的运动计划的开发和完善提供信息。
背景：ClinicalTrials.govNCT05218876;https://tinyurl.com/ysaj9dhm.
未经批准：DERR1-10.2196/40811。
目的：癌症体育锻炼（Phys-Can）联盟的这项子研究的目的是评估和比较高强度和低强度至中等强度运动对肌肉细胞结果的影响。肌肉功能，以及接受（新）辅助化疗的乳腺癌女性的心肺适应性。我们进一步旨在研究包括紫杉烷类药物在内的化疗对肌肉的影响是否与无紫杉烷的化疗不同。
方法：80名最近被诊断为乳腺癌的女性，计划开始（新）辅助化疗，将被随机分配到力量和耐力训练的组合，高强度或低至中等强度。在第一个化疗周期之前（或1周后，当不可能时)(T0)，化疗中途（T1），和完成化疗后（T2）。据估计，大约50％的参与者愿意接受肌肉活检。为了分离治疗本身的效果，一个没有监督培训的常规护理小组也将包括在内，在这个群体中，仅在T0和T2进行肌肉活检的测试和收集。
结果：这项研究由积极抗癌（Aktivmotkreft）（2013年5月）和挪威癌症协会（2018年12月）资助。纳入计划于2016年12月开始，预计最后一名参与者将于2022年12月招募。截至2022年6月，我们招募了38名（19名活检）参与者加入高强度训练组，36名（19名活检）参与者参加了中低强度训练组，17名（16名活检）参与者进入常规护理组。数据分析将于2022年秋季开始。第一个结果预计将于2024年春季发布。
结论：本研究将为乳腺癌患者化疗期间不同训练强度的影响提供新的知识。它将进一步深入了解化疗如何影响肌肉组织，以及不同强度的体育锻炼如何抵消肌肉的治疗副作用。这项研究的结果将为有效且与乳腺癌多学科管理兼容的运动计划的开发和完善提供信息。
背景：ClinicalTrials.govNCT05218876;https://tinyurl.com/ysaj9dhm.
未经批准：DERR1-10.2196/40811。
