Tango for Neuropathy Among Breast Cancer Survivors

NCT ID: NCT05114005

Last Updated: 2025-09-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2024-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer, Breast Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Rhythmic Auditory Stimulation

Intervention Type BEHAVIORAL

Rhythmically-entrained sensorimotor activity.

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

Group Type ACTIVE_COMPARATOR

Evidence-Based Exercise

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rhythmic Auditory Stimulation

Rhythmically-entrained sensorimotor activity.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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);
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lise Worthen-Chaudhari

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lise Worthen-Chaudhari, PhD, MFA

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stephanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30369677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28963591 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38962217 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37658464 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37461666 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2018-00310

Identifier Type: REGISTRY

Identifier Source: secondary_id

R21AG068831

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-15047

Identifier Type: OTHER

Identifier Source: secondary_id

2015C0090

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Compass Course: Efficacy Study
NCT03442686 COMPLETED NA
Improving Cognition After Cancer
NCT04049695 ACTIVE_NOT_RECRUITING NA