Residual Tumor & Response To Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Institut Curie, University Paris, Paris, France.
Department of Medical Oncology, Institut Curie, University Paris, Paris, France.
BMC Cancer. 2022 May 4;22(1):493. doi: 10.1186/s12885-022-09608-y.
Breast cancer (BC) has particular characteristics in young women, with diagnosis at more advanced stages, a poorer prognosis and highly aggressive tumors. In NeoFit, we will use an activity tracker to identify and describe various digital profiles (heart rate, physical activity, and sleep patterns) in women below the age of 45 years on neoadjuvant chemotherapy for BC.
NeoFit is a prospective, national, multicenter, single-arm open-label study. It will include 300 women below the age of 45 years treated with neoadjuvant chemotherapy for BC. Participants will be asked to wear a Withing Steel HR activity tracker round the clock for 12 months. The principal assessments will be performed at baseline, at the end of neoadjuvant chemotherapy and at 12 months. We will evaluate clinical parameters, such as toxicity and the efficacy of chemotherapy, together with quality of life, fatigue, and parameters relating to lifestyle and physical activity. The women will complete REDCap form questionnaires via a secure internet link.
In this study, the use of an activity tracker will enable us to visualize changes in the lifestyle of young women on neoadjuvant chemotherapy for BC, over the course of a one-year period. This exploratory study will provide crucial insight into the digital phenotypes of young BC patients on neoadjuvant chemotherapy and the relationship between these phenotypes and the toxicity and efficacy of treatment. This trial will pave the way for interventional studies involving sleep and physical activity interventions.
Clinicaltrials.gov identifier: NCT05011721 . Registration date: 18/08/2021.
乳腺癌（BC）在年轻女性中具有特殊特征，诊断时处于更晚期，预后更差，肿瘤侵袭性更强。在 NeoFit 中，我们将使用活动追踪器来识别和描述接受新辅助化疗的 45 岁以下 BC 女性的各种数字特征（心率、身体活动和睡眠模式）。
NeoFit 是一项前瞻性、全国性、多中心、单臂、开放标签研究。它将包括 300 名年龄在 45 岁以下接受新辅助化疗的 BC 女性。参与者将被要求佩戴 Withing Steel HR 活动追踪器 12 个月，全天候佩戴。主要评估将在基线、新辅助化疗结束时和 12 个月时进行。我们将评估临床参数，如毒性和化疗疗效，以及生活质量、疲劳和与生活方式及身体活动相关的参数。女性将通过安全的互联网链接填写 REDCap 表格问卷。
在这项研究中，使用活动追踪器将使我们能够在一年的时间内观察到接受新辅助化疗的年轻 BC 女性生活方式的变化。这项探索性研究将为接受新辅助化疗的年轻 BC 患者的数字表型及其与治疗毒性和疗效之间的关系提供重要的见解。该试验将为涉及睡眠和身体活动干预的干预性研究铺平道路。
Clinicaltrials.gov 标识符：NCT05011721。注册日期：2021 年 8 月 18 日。
