Tango for Neuropathy Among Breast Cancer Survivors

Dance-Based Avenues to Advance Nonpharmacologic Treatment of Chemotherapy Effects (DAANCE)

Group dance classes have been found to improve markers of quality of life and physical health (i.e., balance) among some populations engaged in rehabilitation, such as the elderly and individuals with Parkinson Disease. However, such interventions have yet to be studied among cancer survivors despite the relevance of quality of life and physical health within cancer survivorship. Group dance classes are a promising avenue in that they deliver activity-based medicine in a social context, thus potentially improving physical as well as psychosocial aspects of health. To further this avenue of inquiry, we propose to study the effect of dance-based interventions for cancer survivors.

Study Overview

• Status: Completed
• Conditions: Neuropathy; Cancer, Breast
• Intervention / Treatment: Behavioral: Rhythmic Auditory Stimulation; Behavioral: Evidence-Based Exercise

Detailed Description

Participants will be randomized (1:1) to one of two activity intervention arms: Argentine Tango dance or home exercise. Information about neuropathy symptoms, motion, falls incidence, and participant feedback about the interventions will be collected.

Aim1: To evaluate change in postural control over 16 sessions of Tango (exp) vs HEX (control) (n=26 per group) as primary endpoint. As secondary measures, to assess: balance function (i.e., TUG) and patient-reported outcomes (PROs) (i.e., symptoms, pain, fatigue, mood, quality of life) monthly including 1 month post-intervention completion; postural control and symptoms within-session; and falls incidence weekly for 6 months following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures sensitive to neuropathy disease state (i.e., sway variability and area).

Aim2: To evaluate change in gait variability after 16 sessions of Tango (exp) vs HEX (control) (n=26 per group; 1:1 randomization). As secondary measures, to analyze local and orbital dynamic stability (pre, post, and 1mo post-intervention), PROs (monthly), and falls incidence (weekly) following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures of gait variability (i.e., stride-to-stride variability in speed).

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Stephanie Spielman Comprehensive Breast Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Breast cancer survivor stage I-III
• Symptomatic for neuropathy
• postural control outside 70% CI for adults who are middle-aged without neurotrauma
• having completed taxane-based chemotherapy treatment at least 3 months ago;
• able to understand and comply with directions associated with testing and study treatments.

Exclusion Criteria:

• Pre-existing vestibular deficit;
• poorly controlled diabetes (hgA1C > 8);
• non-ambulatory or lower extremity amputation (assistive devices allowed);
• use of cytotoxic or immunotherapy during study (endocrine therapy allowed);
• participation in physical therapy during the study;
• contraindication to participate in Tango due to orthopedic issue (e.g., herniated vertebral disc);

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tango; The intervention will consist of 16 Argentine Tango (Tango) sessions, adapted for neurorehabilitation per Hackney and Earhart (2010). Delivered over 8 weeks at a frequency of 2x per week and duration of 1 hour per session, this program teaches the basics steps of partnered Tango dance.	Behavioral: Rhythmic Auditory Stimulation; Rhythmically-entrained sensorimotor activity.
Active Comparator: Home Exercise (HEX); The control group will consist of an evidence-based, structured home exercise program (HEX) based on the 8 week intervention described by Zimmer et al (2018) and recommended by physical therapists specializing in BC within our organization. This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hour training (i.e., endurance, resistance, and sensorimotor) performed 2x per week	Behavioral: Evidence-Based Exercise; This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hour training (i.e., endurance, resistance, and sensorimotor) performed 2x per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural Control (Variability)	root-mean square of the center of pressure (COP)	At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Intrinsic Motivation	Intrinsic motivation will be measured using a subscale of the Intrinsic Motivation Inventory (IMI). The 6 item Interest/Enjoyment subscale of the IMI represents intrinsic motivation in an activity just performed as a possible score of 6 to 36 with 6 = most; 18 = neutral; 36 = least interesting/enjoyable. Specific items queried include whether the activity just performed was: enjoyable, enjoyed, boring (reverse order), interesting, fun, and able to hold the participant's attention.	Assessed at week 4, week 8, and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural Control (Ellipse Area)	95% ellipse area of the COP	At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Postural Control (Velocity)	velocity of COP	At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Postural Control (Complexity)	sample entropy of the center of pressure (COP). Sample entropy is a non-linear COP measure that determines the irregularity of a time-series. Sample entropy of the resultant COP position will be calculated using the increment calculation method (SEI) with constant values applied of m = 3 and r = 0.3. Entropy of postural responses represents the automatic complexity of neuromotor control that is available to an individual. Sample entropy scores won't go below 0 or above 2, and higher values indicate better complexity in postural response	At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Postural Control (Variability) at Tango Sessions	root-mean square of the center of pressure (COP). The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.	at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks
Postural Control (Ellipse Area) at Tango Sessions	95% ellipse area of the COP. The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.	at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks
Postural Control (Velocity) at Tango Sessions	velocity of COP. The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.	at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks
Postural Control (Complexity) at Tango Sessions	sample entropy of the center of pressure (COP). Sample entropy is a non-linear COP measure that determines the irregularity of a time-series. Sample entropy of the resultant COP position will be calculated using the increment calculation method (SEI) with constant values applied of m = 3 and r = 0.3. Entropy of postural responses represents the automatic complexity of neuromotor control that is available to an individual. Sample entropy scores won't go below 0 or above 2, and higher values indicate better complexity in postural responseThe mean will be taken of all beginning of session data points together and all end of session data points together	at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks
Clinical Measure of Balance Function	The Timed Up-and-Go test, or TUG, (<2 min to administer) is a timed test of a person's ability to stand from a chair, walk 10 feet, turn around, and return to sitting with shorter times indicating better functional balance.	At baseline, week 4 of intervention, and at 4 week follow-up post intervention, up to 12 weeks
Neuropathy Symptoms Score at Tango Sessions	European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire. It is easy to use and filled out by patients themselves. Scores range between 1 to 10 with higher scores indicating greater chemotherapy-induced peripheral neuropathy (CIPN) severity. The mean will be taken of all beginning of session data points together and all end of session data points together	at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks
Neuropathy Symptoms Score	European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire. It is easy to use and filled out by patients themselves. Scores range between 1 to 10 with higher scores indicating greater chemotherapy-induced peripheral neuropathy (CIPN) severity.	At week 8 of intervention and at 4-week follow-up post intervention
Brief Pain Inventory Short Form at Tango Sessions	The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable). The mean will be taken of all beginning of session data points together and all end of session data points together	at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks
Brief Pain Inventory Short Form	The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).	At week 8 of intervention and at 4-week follow-up post intervention
Cancer-Related Fatigue (BFI Scores) at Tango Sessions	The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable). The mean will be taken of all beginning of session data points together and all end of session data points together	at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks
Cancer-Related Fatigue	The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).	At week 8 and at 4-week follow-up visit post intervention
Number of Falls	the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study will be assessed. All reported falls will be totaled and reported by arm.	once at the point of study enrollment
Number of Falls	the number of falls or near falls experienced by the participant since last evaluation/intervention session. All reported falls throughout the intervention time period will be totaled and reported by arm.	at the beginning of each assessment or intervention session for up to 20 sessions, up to 8 weeks
Number of Falls	the number of falls or near falls experienced by the participant in the 6 months post-intervention. All reported falls throughout the follow-up time period will be totaled and reported by arm	6 months post-intervention
Change in Dual-task Function	Dual task function was measured using the Timed-Up-and-Go motor task while counting backward by 3 s (TUGCog), a validated clinical test of dual-task function for which lower values indicate better performance. To perform this test, participants completed the Timed-Up-and Go (TUG) test commonly used in clinical practice wherein individuals stand from a chair with arms, walk 3 meters, turn around, and return to sitting as fast as safely possible (i.e. motor task) while counting out loud and backward by 3 s (i.e. cognitive task). The test is completed 3 times, with rest allowed between trials. Time in seconds per trial is averaged to produce the TUGCog score per timepoint.	Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks
Adherence	Adherence is measured by the number of enrollees who participated through each time point of the study	Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantified Clinical Measure of Balance Function	The Mini Balance Evaluation System Test short version (MiniBEST): evaluates sensory organization, anticipatory and reactive postural control, and dynamic gait indices on a scale from 1 to 28 points (28 represents the highest function measurable by the test); was recently recommended for use in studies of neuropathy; and discriminated BC survivors from controls in at least 1 prior study. Instrumentation of MiniBEST will enable the calculation of spatiotemporal, kinematic, and co-contraction measures	8 weeks
Quantified Clinical Measure of Balance Function	The Mini Balance Evaluation System Test short version (MiniBEST): evaluates sensory organization, anticipatory and reactive postural control, and dynamic gait indices on a scale from 1 to 28 points (28 represents the highest function measurable by the test); was recently recommended for use in studies of neuropathy; and discriminated BC survivors from controls in at least 1 prior study. Instrumentation of MiniBEST will enable the calculation of spatiotemporal, kinematic, and co-contraction measures.	1 month follow-up post-intervention

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Lise Worthen-Chaudhari, PhD, MFA, Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.
• Hackney ME, Earhart GM. Recommendations for Implementing Tango Classes for Persons with Parkinson Disease. Am J Dance Ther. 2010 Jun;32(1):41-52. doi: 10.1007/s10465-010-9086-y.
• 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.
• Lantis K, Schnell P, Bland CR, Wilder J, Hock K, Vargo C, Glover NA, Hackney ME, Lustberg MB, Worthen-Chaudhari L. Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trial and preliminary baseline data. Trials. 2023 Sep 1;24(1):564. doi: 10.1186/s13063-023-07554-z.
• Lantis KD, Schne P, Bland CR, Wilder J, Hock K, Glover NA, Hackney ME, Lustberg MB, Worthen-Chaudhari L. Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trail and preliminary baseline data. Res Sq [Preprint]. 2023 Jun 29:rs.3.rs-2988661. doi: 10.21203/rs.3.rs-2988661/v1.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2015C0090; NCI-2018-00310 (Registry Identifier: CTRP); R21AG068831 (U.S. NIH Grant/Contract); OSU-15047 (Other Identifier: Ohio State University Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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