Department of Cancer Prevention and Environment, Centre Léon Bérard, Lyon, Rhône-Alpes, France.
Inter-University Laboratory of Human Movement Biology, Universite Claude Bernard Lyon 1, Villeurbanne, Auvergne-Rhône-Alpes, France.
BMJ Open. 2022 Apr 7;12(4):e056819. doi: 10.1136/bmjopen-2021-056819.
Patients with metastatic non-small cell lung cancer (mNSCLC) suffer from numerous symptoms linked to disease and treatment which may further impair the patient's overall condition. In addition to its benefits on quality of life and fatigue, physical exercise may improve treatment response, notably due to its known effects on the immune system. The ERICA study is designed to assess the feasibility of a supervised acute physical exercise therapy realised immediately prior immune-chemotherapy infusion in patients with mNSCLC. Secondary objectives will examine the effects of acute exercise combined with an unsupervised home-walking programme on clinical, physical, psychosocial and biological parameters.
ERICA is a prospective, monocentric, randomised controlled, open-label feasibility study conducted at the Centre Léon Bérard Comprehensive Cancer Center (France). Thirty patients newly diagnosed with mNSCLC will be randomised (2:1 ratio) to the 'exercise' or the 'control' group. At baseline and during the last treatment cycle, participants in both groups will receive Physical Activity recommendations, and two nutritional assessments. In the exercise group, participants will receive a 3-month programme consisting of a supervised acute physical exercise session prior to immune-chemotherapy infusion, and an unsupervised home-based walking programme with an activity tracker. The acute exercise consists of 35 min interval training at submaximal intensity scheduled to terminate 15 min prior to infusion. Clinical, physical, biological and psychosocial parameters will be assessed at baseline, 3 and 6 months after inclusion. Biological measures will include immune, inflammatory, metabolic, oxidative stress biomarkers and molecular profiling.
The study protocol was approved by the French ethics committee (Comité de protection des personnes Ile de France II, N°ID-RCB 20.09.04.65226, 8 December 2020). The study is registered on ClinicalTrials.gov (NCT number:NCT04676009) and is at the pre-results stage. All participants will sign an informed consent form. The findings will be disseminated in peer-reviewed journals and academic conferences.
转移性非小细胞肺癌（mNSCLC）患者患有许多与疾病和治疗相关的症状，这些症状可能进一步损害患者的整体状况。除了对生活质量和疲劳的益处外，体育锻炼还可以改善治疗反应，这主要是因为它对免疫系统的已知影响。Erica 研究旨在评估在 mNSCLC 患者中，在免疫化学治疗输注前立即进行监督性急性身体运动治疗的可行性。次要目标将检查急性运动与未经监督的家庭步行计划相结合对临床、身体、心理社会和生物学参数的影响。
Erica 是一项前瞻性、单中心、随机对照、开放标签可行性研究，在里昂贝尔拉德综合癌症中心（法国）进行。30 名新诊断为 mNSCLC 的患者将被随机分为（2:1 比例）“运动”或“对照”组。在基线和最后一个治疗周期，两组参与者都将接受身体活动建议，以及两次营养评估。在运动组中，参与者将接受 3 个月的计划，包括在免疫化学治疗输注前进行监督性急性身体运动治疗，以及在家庭中使用活动追踪器进行未经监督的步行计划。急性运动包括在亚最大强度下进行 35 分钟的间歇训练，计划在输注前 15 分钟结束。在纳入后 3 个月和 6 个月时将评估临床、身体、生物学和心理社会参数。生物学测量将包括免疫、炎症、代谢、氧化应激生物标志物和分子谱。
该研究方案已获得法国伦理委员会的批准（巴黎大区保护委员会 II，编号 ID-RCB 20.09.04.65226，2020 年 12 月 8 日）。该研究已在 ClinicalTrials.gov 上注册（NCT number：NCT04676009），目前处于结果前阶段。所有参与者都将签署知情同意书。研究结果将在同行评议的期刊和学术会议上发表。
