University of Seville, Pirotecnia St. E-41013 Seville, Spain.
Depatment of Human Motricity and Sport Performance, University of Seville, Pirotecnia St. E-41013 Seville, Spain.
Contemp Clin Trials. 2024 Nov;146:107672. doi: 10.1016/j.cct.2024.107672. Epub 2024 Sep 10.
Cancer-related cognitive impairment (CRCI) is a significant but often neglected issue for breast cancer survivors that reduces their quality of life. Physical exercise and cognitive training have emerged as promising strategies for CRCI; however, evidence regarding its effectiveness is still unknown. A recently developed motor-cognitive training (dual-tasks) is proposed to examine its efficacy on executive function, physical fitness, emotional symptomatology, and important muscle-brain crosstalk biomarkers.
The BRAINonFIT study is a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks). Breast cancer survivors (stage I-IIIA) with completed chemotherapy are recruited from QuirónSalud Hospital in Seville. Principal outcomes are executive functions, measured by the Trail Making Test, Stroop and Digit Span Backwards; physical fitness, assessed by muscle strength, cardiorespiratory fitness, and body composition; and several muscle-brain biomarkers analysed by immunoenzymatic assay (ELISA). Secondary endpoints are memory function, intelligence, learning ability, self-reported cognitive function, and emotional symptomatology. Assessments take place after the enrolment (baseline; T), after completing the interventions (5 months after baseline; T), and after completing the follow-up period (8 months after baseline; T).
Given the importance of improving care for breast cancer survivors, this study will provide preliminary evidence for the effectiveness of cognitive-motor training (dual task) as a therapeutic strategy to improve CRCI. Moreover, addressing muscle-brain crosstalk by representative biomarkers will help to elucidate the underlying mechanisms by which this intervention may beneficially impact CRCI.
gov: NCT06073717.
癌症相关认知障碍（CRCI）是乳腺癌幸存者面临的一个重要但常常被忽视的问题，会降低他们的生活质量。身体锻炼和认知训练已成为 CRCI 的有前途的策略；然而，其有效性的证据尚不清楚。最近开发的运动认知训练（双重任务）被提出用于检验其对执行功能、身体健康、情绪症状和重要的肌肉-大脑串扰生物标志物的疗效。
BRAINonFIT 研究是一项随机、对照、纵向（20 周）、三臂、平行研究，具有随访阶段（12 周）。从塞维利亚 QuirónSalud 医院招募完成化疗的乳腺癌幸存者（I 期-IIIA 期）。主要结局是执行功能，通过走迷宫测试、Stroop 测试和数字倒背测试来测量；身体健康，通过肌肉力量、心肺健康和身体成分来评估；以及通过免疫酶联分析（ELISA）分析几种肌肉-大脑生物标志物。次要终点是记忆功能、智力、学习能力、自我报告的认知功能和情绪症状。评估在入组后（基线；T）、完成干预后（基线后 5 个月；T）和完成随访期后（基线后 8 个月；T）进行。
鉴于改善乳腺癌幸存者护理的重要性，本研究将为认知运动训练（双重任务）作为改善 CRCI 的治疗策略的有效性提供初步证据。此外，通过代表性生物标志物解决肌肉-大脑串扰将有助于阐明这种干预可能有益地影响 CRCI 的潜在机制。
gov：NCT06073717。
