Dance-based Avenues to Advance Nonpharmacologic treatment of Chemotherapy Effects (DAANCE): a multicenter trial

NIH RePORTER · NIH · R01 · $916,455 · view on reporter.nih.gov ↗

Abstract

Project Abstract: Breast cancer (BC) is the second most frequently diagnosed cancer among women (second only to skin cancer)[11,12] and up to 80% of survivors experience chemotherapy-induced neuropathy (neuropathy)[14] which causes pain[15,16], falls[17–19], difficulty walking[18,20,21] and diminished quality of life in survivorship [16,20]. To restore mobility and sensation, interventions that address motor control, patient- reported symptoms, and motivation to participate - in combination - are most likely to succeed. Thus, we propose to test the effect of partnered Adapted Argentine Tango (Tango) as an ideal physical activity intervention to simultaneously target restoration of mobility and alleviation of symptoms through musically-entrained movement. Tango is moderate intensity social dance, adapted for individuals with mobility deficits, that delivers sensorimotor and cardiovascular training to rhythmic music. Tango promotes survivor participation through creative engagement and caregiver inclusion. Previous research by the investigators established Tango as feasible for aging survivors (up to 82 years) to engage in with high satisfaction and improvements to CIN-related neurosensorimotor deficits. Therefore, we propose to conduct a multi-center, Phase II, randomized clinical trial investigating Tango in 140 BC survivors with CIN. Our overarching hypothesis is that Tango is associated with improved patient-reported sensation and clinically-measured dual task performance (primary) as well as improved neuromotor control, falls incidence, and patient-reported outcomes (PROs) (secondary) relative to standard of care (SOC) due to response of mediators including inflammation, neurotoxicity, and cognitive load (exploratory) Our rationale: Tango combines the effects of rhythmic auditory stimulation on neuromotor stability; physical activity practice on sensory, functional, and cardiovascular fitness; with social motivation to participate in treatment. Our long-term goal is to optimize prevention and treatment of neuropathy utilizing non- invasive, patient-centered treatment to improve sensory relief and function more definitively and more quickly for more people. Toward this goal, BC survivors with CIN will be randomly assigned to Tango, twice per week, for an 8-week period versus SOC for 4wks followed by one-way crossover to Tango for 8wks. Using an intent-to- treat approach, this innovative pilot study will determine impact of Tango on sensory symptoms (primary AIM1), dual task function (“walking and calculating”; primary AIM2); and explore treatment effects on biomarkers of neurotoxicity and inflammation as well as cognitive load(AIM3). This project will expand our pilot work (R21- AG068831) into a multicenter clinical trial designed to investigate the effect of social dance on sensory relief, functional restoration, and key mechanisms of action among a diverse cohort of BC survivors suffering from chronic CIN-related deficits.

Key facts

NIH application ID
10982211
Project number
1R01AG084676-01A1
Recipient
OHIO STATE UNIVERSITY
Principal Investigator
Maryam B. Lustberg
Activity code
R01
Funding institute
NIH
Fiscal year
2024
Award amount
$916,455
Award type
1
Project period
2024-09-20 → 2029-08-31