Abstract
BACKGROUND: 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 the absence of pharmacologic options, 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 PA-based 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. METHODS: In a multi-center, prospective, randomized controlled clinical trial with optional one-way crossover to intervention, participants are randomly assigned (1:1 ratio) to the Tango experimental or the SOC active control arms. The primary outcome is measured from baseline to after 4 weeks of intervention in patient-reported outcomes (PROs) of sensation. Secondary outcomes include additional PROs, such as fatigue, and clinical measures of interest including dual-task, balance, gait, and upper extremity function 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 measured outcomes. The primary estimand will be the difference in mean change in primary outcome from baseline to week 4 between treatment groups. DISCUSSION: The scientific premise of this study is that Tango, at a dose of 10-35 min performed no more than 2× per week, 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. TRIAL REGISTRATION: This trial was first posted on 12/27/24, which was before enrollment of the first participant on 03/25/25, at ClinicalTrials.gov https://clinicaltrials.gov/study/NCT06749210 under the identifier NCT06749210.