Kiesl David, Kuzdas-Sallaberger Marina, Fuchs David, Brunner Silvana, Kommenda Romana, Tischler Clemens, Hornich Herwig, Akbari Kaveh, Kellermair Jörg, Blessberger Hermann, Ocenasek Helmuth, Hofmann Peter, Zimmer Philipp, Vosko Milan R
Department for Internal Medicine III, Kepler University Hospital, Linz, Austria.
Cardiomed, Cardiological Rehabilitation, Linz, Austria.
Front Neurol. 2022 Mar 25;13:777808. doi: 10.3389/fneur.2022.777808. eCollection 2022.
Epidemiological studies show that increased physical activity is linked to a lower risk of breast cancer and mortality. As a result, physical activity can significantly improve patients' quality of life (QOL) both during and after therapy.Many breast cancer patients demonstrate a decrease in cognitive capacity, referred to as the symptom-complex cancer related cognitive impairment (CRCI). Most frequently reported impairments are mild to moderate deficits in processing speed, attention, memory, and executive functions. Cognitive symptoms persist for months or even years, following medical treatment in roughly 35% of afflicted people, impairing everyday functioning, limiting the ability to return to work, and lowering the overall QOL. Recent studies point toward a key role of inflammatory pathways in the CRCI genesis. Attention to physical activity as a potential supportive care option is therefore increasing. However, evidence for the positive effects of exercise on preventing CRCI is still lacking.
Against this background, the prospective, two-arm, 1:1 randomized, controlled trial investigates the influence of first line chemotherapy accompanied by exercise training on preventing CRCI in 126 patients with breast cancer at the local University Hospital. The study will evaluate biomarkers and secondary assessments suspected to be involved in the pathogenesis of CRCI in addition to objective (primary outcome) and subjective cognitive function. CRCI is believed to be connected to either functional and/or morphological hippocampal damage due to chemotherapy. Thus, cerebral magnetic resonance imaging (MRI) and hippocampal volume measurements are performed. Furthermore, a specific neuropsychological test battery for breast cancer patients has been developed to detect early signs of cognitive impairments in patients and to be integrated into practice.
This study will explore how a long-term supervised exercise intervention program might prevent CRCI, enables optimization of supportive care and objectifies limits of psychological and physical resilience in breast cancer patients during and after chemotherapy treatment.
ClinicalTrials.gov: Identifier: NCT04789187. Registered on 09 March 2021.
流行病学研究表明，增加身体活动与降低乳腺癌风险和死亡率相关。因此，身体活动可显著改善患者在治疗期间及治疗后的生活质量（QOL）。许多乳腺癌患者表现出认知能力下降，这被称为症状复合体癌症相关认知障碍（CRCI）。最常报告的障碍是处理速度、注意力、记忆力和执行功能方面的轻度至中度缺陷。认知症状会持续数月甚至数年，在约35%的患者接受治疗后仍存在，损害日常功能，限制重返工作岗位的能力，并降低总体生活质量。最近的研究表明炎症途径在CRCI的发生中起关键作用。因此，将身体活动作为一种潜在的支持性护理选择越来越受到关注。然而，运动对预防CRCI的积极作用仍缺乏证据。
在此背景下，这项前瞻性、双臂、1:1随机对照试验在当地大学医院对126例乳腺癌患者进行研究，探讨一线化疗联合运动训练对预防CRCI的影响。该研究除了评估客观（主要结局）和主观认知功能外，还将评估疑似参与CRCI发病机制的生物标志物和二次评估。CRCI被认为与化疗导致的功能性和/或形态学海马损伤有关。因此，进行了脑磁共振成像（MRI）和海马体积测量。此外，还开发了一套针对乳腺癌患者的特定神经心理测试组合，以检测患者认知障碍的早期迹象并应用于临床实践。
本研究将探讨长期的有监督运动干预计划如何预防CRCI，优化支持性护理，并明确乳腺癌患者在化疗期间及化疗后心理和身体恢复力的限度。
ClinicalTrials.gov：标识符：NCT04789187。于2021年3月9日注册。
