Tango for Neuropathy Among Breast Cancer Survivors

Novel Interventions for Chemotherapy-Induced Neuropathy

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: Active, not recruiting
• 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 hr 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 hr 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)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural Control (ellipse area)	95% ellipse area of the COP	8 weeks
Postural Control (velocity)	velocity of COP	8 weeks
Postural Control (complexity)	sample entropy of COP	8 weeks
Postural Control (variability)	root-mean square of the center of pressure (COP)	at the beginning of each assessment or intervention session for up to 20 sessions
Postural Control (variability)	root-mean square of the center of pressure (COP)	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Postural Control (ellipse area)	95% ellipse area of the COP	at the beginning of each assessment or intervention session for up to 20 sessions
Postural Control (ellipse area)	95% ellipse area of the COP	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Postural Control (velocity)	velocity of COP	at the beginning of each assessment or intervention session for up to 20 sessions
Postural Control (velocity)	velocity of COP	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Postural Control (complexity)	sample entropy of COP	at the beginning of each assessment or intervention session for up to 20 sessions
Postural Control (complexity)	sample entropy of COP	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Postural Control (variability)	root-mean square of the center of pressure (COP)	1 month follow up post-intervention
Postural Control (ellipse area)	95% ellipse area of the COP	1 month follow up post-intervention
Postural Control (velocity)	velocity of COP	1 month follow up post-intervention
Postural Control (complexity)	sample entropy of COP	1 month follow up post-intervention
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.	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.	1 month follow-up post-intervention
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 that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.	at the beginning of each assessment or intervention session for up to 20 sessions
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 that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
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 that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.	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 that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.	1 month follow-up post-intervention
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 the beginning of each assessment or intervention session for up to 20 sessions
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 the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
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).	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).	1 month follow-up post-intervention
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 the beginning of each assessment or intervention session for up to 20 sessions
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 the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
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).	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).	1 month follow-up post-intervention
Falls Incidence	the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study	once at the point of study enrollment
Falls Incidence	the number of falls or near falls experienced by the participant since last evaluation/intervention session	at the beginning of each assessment or intervention session for up to 20 sessions
Falls Incidence	the number of falls or near falls experienced by the participant in the 6 months post-intervention	6 months post-intervention

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.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): August 14, 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 (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

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

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