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Cancer, BreastNCT05114005

Tango for Neuropathy Among Breast Cancer Survivors

A study testing Rhythmic Auditory Stimulation and Evidence-Based Exercise in people with Cancer, Breast and Neuropathy, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Cancer, Breast, Neuropathy
What is being tested?
Rhythmic Auditory Stimulation and Evidence-Based Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
15 Aug 2021to 15 Apr 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Stephanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Rhythmic Auditory Stimulation, Evidence-Based Exercise
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rhythmic Auditory StimulationBehavioural

    Rhythmically-entrained sensorimotor activity.

  • Evidence-Based ExerciseBehavioural

    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

Study groups in NCT05114005
Study groupRoleWhat they receive
TangoExperimentalThe 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.
Receives: Behavioral: Rhythmic Auditory Stimulation
Home Exercise (HEX)Active comparatorThe 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
Receives: Behavioral: Evidence-Based Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postural Control (Variability)

    root-mean square of the center of pressure (COP)

    Measured: At baseline, week 8 of intervention, and at 4 week follow-up post intervention

  2. 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.

    Measured: Assessed at week 4, week 8, and week 12

Secondary outcomes (19)
  1. Postural Control (Ellipse Area)

    95% ellipse area of the COP

    Measured: At baseline, week 8 of intervention, and at 4 week follow-up post intervention

  2. Postural Control (Velocity)

    velocity of COP

    Measured: At baseline, week 8 of intervention, and at 4 week follow-up post intervention

  3. 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

    Measured: At baseline, week 8 of intervention, and at 4 week follow-up post intervention

  4. 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.

    Measured: at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

  5. 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.

    Measured: at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

  6. 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.

    Measured: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

  7. 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

    Measured: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

  8. 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.

    Measured: At baseline, week 4 of intervention, and at 4 week follow-up post intervention, up to 12 weeks

  9. 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

    Measured: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

  10. 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.

    Measured: At week 8 of intervention and at 4-week follow-up post intervention

  11. 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

    Measured: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

  12. 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).

    Measured: At week 8 of intervention and at 4-week follow-up post intervention

  13. 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

    Measured: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

  14. 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).

    Measured: At week 8 and at 4-week follow-up visit post intervention

  15. 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.

    Measured: once at the point of study enrollment

  16. 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.

    Measured: at the beginning of each assessment or intervention session for up to 20 sessions, up to 8 weeks

  17. 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

    Measured: 6 months post-intervention

  18. 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.

    Measured: Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks

  19. Adherence

    Adherence is measured by the number of enrollees who participated through each time point of the study

    Measured: Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start15 Aug 2021
  3. Primary completion15 Apr 2024
  4. Study completion15 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05114005
Sponsor's protocol ID
2015C0090
Other IDs
NCI-2018-00310, R21AG068831, OSU-15047
Status last verified
Aug 2025
First submitted
20 Sep 2021
Last updated
15 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30369677
  • 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.

    PubMed 28963591
  • Worthen-Chaudhari L, Schnell P, Bland C, Lantis K, Wilder J, Hock K, Alwan A, Hawke A, Bader G, Davenport AP, Gatti-Mays ME, Johnson KC, Quiroga DM, Sardesai SD, Stover DG, Wesolowski R, Williams NO, Crasta JE, Hackney ME, Lustberg MB. Effect of tango versus exercise on chemotherapy-induced neuropathy after breast cancer treatment: a Phase II randomized controlled trial. Res Sq [Preprint]. 2026 Aug 5:rs.3.rs-10168428. doi: 10.21203/rs.3.rs-10168428/v1.

    PubMed 42620214
  • 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.

    PubMed 38962217
  • 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.

    PubMed 37658464
  • 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.

    PubMed 37461666

Questions about this trial

What is this clinical trial studying?

A study testing Rhythmic Auditory Stimulation and Evidence-Based Exercise in people with Cancer, Breast and Neuropathy, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural Control (Variability) (time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05114005, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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