Luciani Bhillie, Carlson Martha, McNally Gretchen, Hackney Madeleine E, Crasta Jewel E, Schnell Patrick, Lustberg Maryam B, Worthen-Chaudhari Lise
The Ohio State University Wexner Medical Center.
The Ohio State University James Cancer Hospital: The Ohio State University Comprehensive Cancer Center Arthur G James Cancer Hospital and Richard J Solove Research Institute.
Res Sq. 2025 Jul 7:rs.3.rs-6814353. doi: 10.21203/rs.3.rs-6814353/v1.
Breast cancer (BC) is among the most common forms of cancer, particularly among women. Chemotherapies that are most effective in treating BC are known to cause chemotherapy-induced neuropathy (CIN), thus leaving survivors with sensory deficits including pain, numbness, and tingling in the extremities; functional deficits such as impaired neuromotor control and motor-cognitive integration; reduced quality of life; and increased fall risk. Current pharmacologic treatments show limited efficacy and create additional unwanted side effects. In contrast, physical activity (PA) has emerged as a promising nonpharmacologic candidate for managing CIN symptoms. The purpose of this trial is to evaluate the effect of Adapted Argentine Tango (Tango) as a potential treatment for CIN. Toward this end, we will assess the intervention effect of Tango vs. the standard of care (SOC) on patient-reported outcomes of sensation, clinically-relevant measures of function, and potential mechanisms of action. We hypothesize that 4 weeks of Tango practice will improve sensation and function more than SOC among BC survivors with CIN and demonstrated balance dysfunction.
In a multi-center, prospective, randomized controlled clinical trial, participants are randomly assigned (1:1 ratio) to the Tango experimental or the SOC active control arms. Primary outcomes are measured from baseline to after 4 weeks of intervention in patient-reported outcomes (PROs) of sensation and dual-task function. Secondary outcomes include additional PROs, such as fatigue, and clinical measures of interest after 4 and 8 weeks of intervention and 1 month following intervention completion. Exploratory measures include postural control, gait stability, cognitive load, and blood-based biomarker concentrations. Linear mixed models will be used to model changes in PROs and function. The primary estimand will be the difference in mean change in primary outcomes from baseline to week 4 between treatment groups.
The scientific premise of this study is that Tango stands to improve CIN symptoms significantly more than the current standard of care by combining PA with auditory-motor entrainment and social engagement. Our findings may lead to a safe non-pharmacologic intervention that improves CIN-related deficits.
This trial was first posted on 12/27/24 at ClinicalTrials.gov under the identifier NCT06749210.
乳腺癌（BC）是最常见的癌症形式之一，在女性中尤为常见。已知对治疗乳腺癌最有效的化疗会导致化疗引起的神经病变（CIN），从而使幸存者出现感觉缺陷，包括四肢疼痛、麻木和刺痛；功能缺陷，如神经运动控制和运动认知整合受损；生活质量下降；以及跌倒风险增加。目前的药物治疗效果有限，并会产生额外的不良副作用。相比之下，体育活动（PA）已成为管理CIN症状的一种有前景的非药物选择。本试验的目的是评估适应性阿根廷探戈（探戈）作为CIN潜在治疗方法的效果。为此，我们将评估探戈与标准护理（SOC）对患者报告的感觉结果、临床相关功能指标以及潜在作用机制的干预效果。我们假设，对于患有CIN且存在平衡功能障碍的乳腺癌幸存者，进行4周的探戈练习比SOC更能改善感觉和功能。
在一项多中心、前瞻性、随机对照临床试验中，参与者被随机分配（1:1比例）到探戈实验组或SOC活性对照组。主要结局指标在基线至干预4周后进行测量，包括患者报告的感觉结局（PROs）和双任务功能。次要结局指标包括额外的PROs，如疲劳，以及干预4周和8周后以及干预完成后1个月时感兴趣的临床指标。探索性指标包括姿势控制、步态稳定性、认知负荷和血液中生物标志物浓度。线性混合模型将用于对PROs和功能的变化进行建模。主要估计值将是治疗组从基线到第4周主要结局平均变化的差异。
本研究的科学前提是，探戈通过将体育活动与听觉-运动同步和社交参与相结合，比当前的标准护理更能显著改善CIN症状。我们的研究结果可能会带来一种安全的非药物干预措施，改善与CIN相关的缺陷。
本试验于2024年12月27日首次在ClinicalTrials.gov上发布，标识符为NCT06749210。
