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一项新诊断为乳腺癌的女性在癌症治疗前使用多模式方案(ATENTO)预防神经毒性与在癌症治疗期间全程使用该方案的随机临床试验方案。

Neurotoxicity prevention with a multimodal program (ATENTO) prior to cancer treatment versus throughout cancer treatment in women newly diagnosed for breast cancer: Protocol for a randomized clinical trial.

机构信息

Department of Physiotherapy, Faculty of Health Sciences, University of Granada, Granada, Spain.

"CUIDATE" Support Unit for Oncology Patients (UAPO), University of Granada, Granada, Spain.

出版信息

Res Nurs Health. 2021 Aug;44(4):598-607. doi: 10.1002/nur.22136. Epub 2021 May 7.

DOI:10.1002/nur.22136
PMID:33963594
Abstract

A current challenge in breast cancer (BC) patients is how to reduce the side effects of cancer and cancer treatments and prevent a decrease in quality of life (QoL). Neurotoxic side effects, especially from chemotherapy, are present in up to 75% of women with BC, which implies a large impact on QoL. There is a special interest in the preventive possibilities of therapeutic exercise (TE) for these neurological sequelae, and the benefits of TE could be improved when it is combined with vagal activation techniques (VATs). This superiority randomized controlled trial aims to examine the feasibility and efficacy of an 8-week multimodal intervention (ATENTO) based on moderate-vigorous intensity and individualized TE (aerobic and strength exercises) and VAT (myofascial and breathing exercises), on neurotoxicity prevention in women with BC before starting adjuvant chemotherapy (ATENTO-B) versus throughout adjuvant chemotherapy (ATENTO-T). A sample of 56 women newly diagnosed with BC, as calculated with a power of 85%, will be randomly allocated into these two groups. This study could provide an impetus for the introduction of early multimodal intervention methods to prevent neurotoxicity and consequently avoid the QoL deterioration that BC patients presently suffer throughout their treatments.

摘要

目前乳腺癌(BC)患者面临的一个挑战是如何降低癌症和癌症治疗的副作用,预防生活质量(QoL)下降。多达 75%的 BC 女性存在神经毒性副作用,尤其是来自化疗的副作用,这对 QoL 有很大影响。因此,人们特别关注治疗性运动(TE)对这些神经后遗症的预防可能性,而当 TE 与迷走神经激活技术(VAT)结合使用时,其益处可能会提高。这项随机对照试验旨在检验基于中高强度和个体化 TE(有氧运动和力量训练)和 VAT(筋膜和呼吸训练)的 8 周多模式干预(ATENTO)在预防开始辅助化疗前(ATENTO-B)和辅助化疗期间(ATENTO-T)女性 BC 患者神经毒性方面的可行性和疗效。根据 85%的功效计算,将 56 名新诊断为 BC 的女性随机分配到这两组中。这项研究可能为引入早期多模式干预方法提供动力,以预防神经毒性,并避免 BC 患者在治疗过程中目前所经历的 QoL 恶化。

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