DAANCE FOR CHEMOTHERAPY-INDUCED NEUROPATHY (DAANCE)

November 3, 2025 updated by: Lise Worthen-Chaudhari, Ohio State University Comprehensive Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Maryam Lustberg, MD, MPH
    • Ohio
      • Columbus, Ohio, United States, 43220
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Lise Worthen-Chaudhari, PhD, MFA, CMES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcome (PRO) - CIN sensation
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcome (PRO) - hot/cold sensation
Time Frame: 4 weeks; 8 weeks; 12 weeks
Sensation of hot and/or cold (11 point Likert scale).
4 weeks; 8 weeks; 12 weeks
EORTC-CIPN 20
Time Frame: mid-intervention (4weeks); post -intervention (8 weeks); 1 month follow up post intervention
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
Time Frame: 4 weeks; 8 weeks; 12 weeks
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
Time Frame: 4 weeks; 8 weeks; 12 weeks
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)
Time Frame: 4 weeks; 8 weeks; 12 weeks
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)
Time Frame: 4 weeks; 8 weeks; 12 weeks
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
Time Frame: 4 weeks; 8 weeks; 12 weeks
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
Time Frame: 4 weeks; 8 weeks; 12 weeks; 6 months following intervention end
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)
Time Frame: 4 weeks (Control group); 8 weeks (Intervention group)
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
Time Frame: 4 weeks; 8 weeks; 12 weeks
Postural sway while standing still with eyes closed.
4 weeks; 8 weeks; 12 weeks
Six minute walk test (6mwt)
Time Frame: 4 weeks; 8 weeks
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
Time Frame: 4 weeks; 8 weeks
Stability between gait strides over the period of the 6mwt.
4 weeks; 8 weeks
Upper Extremity Function
Time Frame: 4 weeks; 8 weeks; 12 weeks
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brain Activity
Time Frame: 4 weeks (Control group); 8 weeks (Intervention group)
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
Time Frame: 4 weeks (Control group); 8 weeks (Intervention group)
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
Time Frame: 4 weeks (Control group); 8 weeks (Intervention group)
Neurofilament chains, light density (NfL)
4 weeks (Control group); 8 weeks (Intervention group)
Blood-based biomarkers of neuroplasticity
Time Frame: 4 weeks (Control group); 8 weeks (Intervention group)
BDNF and GFAP. These will be measured using the same units of measurement
4 weeks (Control group); 8 weeks (Intervention group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University Comprehensive Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yale University
Emory University
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings