DAANCE FOR CHEMOTHERAPY-INDUCED NEUROPATHY (DAANCE)

DANCE-BASED AVENUES TO ADVANCE NONPHARMACOLOGIC TREATMENT OF CHEMOTHERAPY EFFECTS (DAANCE): A MULTICENTER TRIAL

Up to 80% of breast cancer survivors experience chemotherapy-induced neuropathy that impairs quality of life and increases fall risk long into survivorship, yet treatment options for neuropathy remain limited. The successful treatment will target neurophysiologic mechanisms for restoring function while addressing patient-reported symptoms and participation in treatment. Toward this end, the investigators propose to study a noninvasive, social sensorimotor intervention - Adapted Argentine Tango - which targets motor control restoration, symptom alleviation, and treatment participation in concert.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Neuropathy; Cancer of the Breast
• Intervention / Treatment: Behavioral: Tango

Detailed Description

This study will investigate a noninvasive, social, sensorimotor intervention which targets motor control restoration, symptom alleviation, and treatment participation in concert: partnered Adapted Argentine Tango (Tango). This project will expand the investigators' 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 chemotherapy-induced sensorimotor deficits.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lise Worthen-Chaudhari, PhD, MFA, CMES; Phone Number: (1) + 614-293-6281; Email: lise.worthen-chaudhari@osumc.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University
      • Contact: Maryam Lustberg, MD, MPH; Email: maryam.lustberg@yale.edu
      • Principal Investigator: Maryam Lustberg, MD, MPH
  • Ohio
    • Columbus, Ohio, United States, 43220
      • Recruiting
      • The Ohio State University
      • Contact: Lise Worthen-Chaudhari, PhD, MFA, CMES; Phone Number: (1) + 614-293-6281; Email: lise.worthen-chaudhari@osumc.edu
      • Principal Investigator: Lise Worthen-Chaudhari, PhD, MFA, CMES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Breast Cancer (BC) diagnosis of Stage I-IV including metastatic disease
• completed taxane-based chemotherapy for BC at least 3 months ago (no limit on how long ago)
• symptomatic for chemotherapy-induced neuropathy (self-report)
• postural control score that indicates potential fall-risk
• able to understand and comply with directions associated with testing and study treatments

Exclusion Criteria:

• pre-existing vestibular dysfunction
• poorly controlled diabetes (hgA1C>=8)
• non-ambulatory (assistive and prosthetic devices allowed)
• hearing impairment resulting in less than 10% hearing bilaterally
• contraindication to participate in the experimental physical activity per the treating oncologist due to additional condition (e.g., herniated disc, unstable bone metastases)
• currently in activity-based therapy (e.g., physical therapy, occupational therapy). May enroll if still meet eligibility criteria once activity-based therapy is complete.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 4 weeks of usual care followed by optional 1-way crossover to 8 weeks of Intervention (partnered, adapted tango dance)
Experimental: Experimental; 8 weeks of intervention (partnered, adapted tango dance)	Behavioral: Tango; The intervention being studied is a 16 session intervention (2x4-week modules), delivered over an 8-week period by community-based individuals with expertise in dance and patient care and certified in Adapted Tango or AdapTango dance instruction. Steps available to teach, including order and cues to teach them, are detailed in Hackney's AdapTango manual. All steps are based on the Argentine Tango steps that emerged within working class community centers in Buenos Aires, Argentina (milongas) in the late 1800s and have been adapted by the investigators for use as medical exercise among people with mobility deficits. Of note, Argentine Tango is distinct from, and the precursor for, the American Tango style of competitive ballroom dance: where American Tango highlights showmanship and complicated footwork, Argentine Tango prioritizes connection between partners and musicality within a basic walk motion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcome (PRO) - CIN sensation	Sensation of numbness/tingling on 0-10 scale; minimum value 0 (no numbness/tingling); maximum value 10 (worst numbness/tingling)	4 weeks
Dual-task function	Ability to move and think at the same time as measured by time to complete the Timed-Up-and-Go (TUG) test with concurrent cognitive task (i.e., counting backward by some number while completing a defined movement task)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcome (PRO) - hot/cold sensation	Sensation of hot and/or cold (11 point Likert scale).	4 weeks; 8 weeks; 12 weeks
EORTC-CIPN 20	European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy symptoms inventory (CIPN 20),	mid-intervention (4weeks); post -intervention (8 weeks); 1 month follow up post intervention
Brief Fatigue Inventory	The Brief Fatigue Inventory (BFI) is a short questionnaire used to quickly assess the severity of fatigue, particularly in cancer patients, by measuring both the level of tiredness and how much fatigue interferes with daily activities, allowing for rapid evaluation in clinical settings or research studies; it consists of nine items where patients rate their fatigue on a scale from 0 to 10, with higher scores indicating greater fatigue severity.	4 weeks; 8 weeks; 12 weeks
Brief Pain Inventory	The Brief Pain Inventory (BPI) is a self-reported questionnaire used to assess the severity of pain and how much it interferes with a person's daily activities, including aspects like mood, work, sleep, and social interactions. It measures pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable) across different timeframes (current, average, worst pain) while also evaluating the impact of pain on various life functions on a similar 0-10 scale; it comes in both short and long forms, with the long form including more detailed questions about pain characteristics and treatment history.	4 weeks; 8 weeks; 12 weeks
Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	The PRO-CTCAE assessment, which stands for "Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events," is a measurement system designed by the National Cancer Institute (NCI) to capture and evaluate the symptomatic side effects experienced by cancer patients during clinical trials, allowing patients to self-report on the frequency, severity, interference, and presence/absence of symptoms like pain, fatigue, nausea, and skin reactions, providing a more patient-centric perspective on treatment toxicity compared to clinician-based assessments alone.	4 weeks; 8 weeks; 12 weeks
Physical Health Questionnaire-2 (PHQ-2)	The PHQ-2 asks how often a patient has experienced depressed mood or anhedonia in the last two weeks	4 weeks; 8 weeks; 12 weeks
Generalized Anxiety Questionnaire	Each question has a 4-point scale, ranging from 1, "not at all", to 4, "nearly every day".	4 weeks; 8 weeks; 12 weeks
Falls	Report of whether you have fallen or lost your balanced since we last spoke with you	4 weeks; 8 weeks; 12 weeks; 6 months following intervention end
The Mini Balance Evaluation Systems Test (MiniBEST)	The Mini-BESTest (Balance Evaluation Systems Test) is a 14-item test that measures balance, functional mobility, and gait by assessing dynamic balance, anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.	4 weeks (Control group); 8 weeks (Intervention group)
Biomechanical measures of postural control	Postural sway while standing still with eyes closed.	4 weeks; 8 weeks; 12 weeks
Six minute walk test (6mwt)	A "6 minute walk test" (6MWT) is a medical assessment where a person walks as far as they can in a designated area for six minutes, with the primary goal of measuring their functional exercise capacity, usually used to evaluate patients with conditions affecting their breathing or mobility, like heart failure or lung disease; the distance walked during those six minutes is the key measurement recorded as the "6-minute walk distance" (6MWD)	4 weeks; 8 weeks
Gait stability	Stability between gait strides over the period of the 6mwt.	4 weeks; 8 weeks
Upper Extremity Function	We assess upper extremity function using the "back scratch test" which measures upper body flexibility and shoulder mobility. Participants reach both hands toward each other behind their backs and staff measure the distance remaining between their fingertips.	4 weeks; 8 weeks; 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Activity	Electroencephalography (EEG)-based measures of brain activity during performance of functional activities (e.g., walking standing, thinking). We will analyze Alpha and Gamma frequencies with regard to amplitude and timing of peak activity.	4 weeks (Control group); 8 weeks (Intervention group)
Blood-based biomarkers of inflammation	IL-6, IL-7, IL-8, IL-9, IL-10, TNF-alpha, IRN-gamma, MCP-1	4 weeks (Control group); 8 weeks (Intervention group)
Blood-based biomarkers of neurotoxity	Neurofilament chains, light density (NfL)	4 weeks (Control group); 8 weeks (Intervention group)
Blood-based biomarkers of neuroplasticity	BDNF and GFAP. These will be measured using the same units of measurement	4 weeks (Control group); 8 weeks (Intervention group)

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Yale University; Emory University; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Lise B Worthen-Chaudhari, PhD, MFA, CMES, Ohio State University; Principal Investigator: Maryam B Lustberg, MD, MPH, Yale University

Publications and helpful links

General Publications

• Mezzanotte JN, Grimm M, Shinde NV, Nolan T, Worthen-Chaudhari L, Williams NO, Lustberg MB. Updates in the Treatment of Chemotherapy-Induced Peripheral Neuropathy. Curr Treat Options Oncol. 2022 Jan;23(1):29-42. doi: 10.1007/s11864-021-00926-0. Epub 2022 Feb 15.
• Worthen-Chaudhari L, Bing J, Schmiedeler JP, Basso DM. A new look at an old problem: defining weight acceptance in human walking. Gait Posture. 2014;39(1):588-92. doi: 10.1016/j.gaitpost.2013.09.012. Epub 2013 Sep 28.
• Worthen-Chaudhari L, Schnell PM, Hackney ME, Lustberg MB. Partnered dance evokes greater intrinsic motivation than home exercise as therapeutic activity for chemotherapy-induced deficits: secondary results of a randomized, controlled clinical trial. Front Psychol. 2024 Jun 19;15:1383143. doi: 10.3389/fpsyg.2024.1383143. eCollection 2024.
• Worthen-Chaudhari L, Lamantia MT, Monfort SM, Mysiw W, Chaudhari AMW, Lustberg MB. Partnered, adapted argentine tango dance for cancer survivors: A feasibility study and pilot study of efficacy. Clin Biomech (Bristol). 2019 Dec;70:257-264. doi: 10.1016/j.clinbiomech.2019.08.010. Epub 2019 Aug 22.
• Worthen-Chaudhari LC, Monfort SM, Bland C, Pan X, Chaudhari AMW. Characterizing within-subject variability in quantified measures of balance control: A cohort study. Gait Posture. 2018 Jul;64:141-146. doi: 10.1016/j.gaitpost.2018.05.031. Epub 2018 Jun 2.
• Worthen-Chaudhari LC, Crasta JE, Schnell PM, Lantis K, Martis J, Wilder J, Bland CR, Hackney ME, Lustberg MB. Neurologic dance training and home exercise improve motor-cognitive dual-task function similarly, but through potentially different mechanisms, among breast cancer survivors with chemotherapy-induced neuropathy: Initial results of a randomized, controlled clinical trial. J Alzheimers Dis. 2025 Jun;105(4):1114-1130. doi: 10.1177/13872877241291440. Epub 2024 Nov 25.
• Luciani B, Carlson M, McNally G, Hackney ME, Crasta JE, Schnell P, Lustberg MB, Worthen-Chaudhari L. Dance-based avenues to advance nonpharmacologic treatment of chemotherapy effects (DAANCE): Study protocol for a multi-center, randomized controlled trial. Res Sq [Preprint]. 2025 Jul 7:rs.3.rs-6814353. doi: 10.21203/rs.3.rs-6814353/v1.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): August 15, 2029

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: music; survivorship; dance
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Membrane Proteins; DNA-Binding Proteins; Transcription Factors; Membrane Transport Proteins; Carrier Proteins; Nucleocytoplasmic Transport Proteins; Hypoxia-Inducible Factor 1; Basic Helix-Loop-Helix Transcription Factors; Aryl Hydrocarbon Receptor Nuclear Translocator
• Other Study ID Numbers: OSU-24277 (Other Identifier: Ohio State Comprehensive Cancer Center); R01AG084676 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data collected will be preserved and shared publicly upon publication to the NCI Cancer Research Data Commons (CRDC), a family of data repositories that provide cancer researchers with the ability to share diverse data types to maximize FAIR (i.e., Findable, Accessible, Interoperable, and Reusable) sharing of data. Shared data will be coded using unique filename identifiers that are not traceable to protected health information in order to enable future researchers to confirm results and/or incorporate these data in a metanalysis or similar larger study of relevant effects. The rationale is to share data for public access for other scientific learning and informational purposes to advance the knowledge base in these fields and to help researchers conduct secondary analysis on our broad range of datasets.
• IPD Sharing Time Frame: Data will be made available upon publication within a peer-reviewed journal. Data will be available for as long as the NCI Cancer Research Data Commons (CRDC) supports access.
• IPD Sharing Access Criteria: Anyone with access to the NCI Cancer Research Data Commons (CRDC)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No