NCT06749210

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
40mo left

Started Feb 2025

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Feb 2025Aug 2029

First Submitted

Initial submission to the registry

December 17, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 19, 2025

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2029

Last Updated

November 5, 2025

Status Verified

July 1, 2025

Enrollment Period

4.5 years

First QC Date

December 17, 2024

Last Update Submit

November 3, 2025

Conditions

Cancer of the BreastChemotherapy-induced Neuropathy

Keywords

survivorshipmusicdance

Outcome Measures

Primary Outcomes (2)

  • Patient-Reported Outcome (PRO) - CIN sensation

    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

    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 Outcomes (13)

  • Patient-Reported Outcome (PRO) - hot/cold sensation

    4 weeks; 8 weeks; 12 weeks

  • EORTC-CIPN 20

    mid-intervention (4weeks); post -intervention (8 weeks); 1 month follow up post intervention

  • Brief Fatigue Inventory

    4 weeks; 8 weeks; 12 weeks

  • Brief Pain Inventory

    4 weeks; 8 weeks; 12 weeks

  • Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    4 weeks; 8 weeks; 12 weeks

  • +8 more secondary outcomes

Other Outcomes (4)

  • Brain Activity

    4 weeks (Control group); 8 weeks (Intervention group)

  • Blood-based biomarkers of inflammation

    4 weeks (Control group); 8 weeks (Intervention group)

  • Blood-based biomarkers of neurotoxity

    4 weeks (Control group); 8 weeks (Intervention group)

  • +1 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

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

Interventions

TangoBEHAVIORAL

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.

Experimental

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43220, United States

RECRUITING

Related Publications (7)

  • Worthen-Chaudhari L, Bing J, Schmiedeler JP, Basso DM. A new look at an old problem: defining weight acceptance in human walking. Gait Posture. 2014;39(1):588-92. doi: 10.1016/j.gaitpost.2013.09.012. Epub 2013 Sep 28.

    PMID: 24139684BACKGROUND

  • 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.

    PMID: 38962217BACKGROUND

  • Worthen-Chaudhari LC, Crasta JE, Schnell PM, Lantis K, Martis J, Wilder J, Bland CR, Hackney ME, Lustberg MB. Neurologic dance training and home exercise improve motor-cognitive dual-task function similarly, but through potentially different mechanisms, among breast cancer survivors with chemotherapy-induced neuropathy: Initial results of a randomized, controlled clinical trial. J Alzheimers Dis. 2025 Jun;105(4):1114-1130. doi: 10.1177/13872877241291440. Epub 2024 Nov 25.

    PMID: 39584292BACKGROUND

  • Worthen-Chaudhari L, Lamantia MT, Monfort SM, Mysiw W, Chaudhari AMW, Lustberg MB. Partnered, adapted argentine tango dance for cancer survivors: A feasibility study and pilot study of efficacy. Clin Biomech (Bristol). 2019 Dec;70:257-264. doi: 10.1016/j.clinbiomech.2019.08.010. Epub 2019 Aug 22.

    PMID: 31751861BACKGROUND

  • Worthen-Chaudhari LC, Monfort SM, Bland C, Pan X, Chaudhari AMW. Characterizing within-subject variability in quantified measures of balance control: A cohort study. Gait Posture. 2018 Jul;64:141-146. doi: 10.1016/j.gaitpost.2018.05.031. Epub 2018 Jun 2.

    PMID: 29908434BACKGROUND

  • Mezzanotte JN, Grimm M, Shinde NV, Nolan T, Worthen-Chaudhari L, Williams NO, Lustberg MB. Updates in the Treatment of Chemotherapy-Induced Peripheral Neuropathy. Curr Treat Options Oncol. 2022 Jan;23(1):29-42. doi: 10.1007/s11864-021-00926-0. Epub 2022 Feb 15.

    PMID: 35167004BACKGROUND

  • Luciani B, Carlson M, McNally G, Hackney ME, Crasta JE, Schnell P, Lustberg MB, Worthen-Chaudhari L. Dance-based avenues to advance nonpharmacologic treatment of chemotherapy effects (DAANCE): Study protocol for a multi-center, randomized controlled trial. Res Sq [Preprint]. 2025 Jul 7:rs.3.rs-6814353. doi: 10.21203/rs.3.rs-6814353/v1.

    PMID: 40671809DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Aryl Hydrocarbon Receptor Nuclear Translocator

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nucleocytoplasmic Transport ProteinsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsHypoxia-Inducible Factor 1Basic Helix-Loop-Helix Transcription FactorsDNA-Binding ProteinsMembrane ProteinsTranscription Factors

Study Officials

  • Lise B Worthen-Chaudhari, PhD, MFA, CMES

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • Maryam B Lustberg, MD, MPH

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Worthen-Chaudhari, PhD, MFA, CMES

CONTACT

(1) + 614-293-6281lise.worthen-chaudhari@osumc.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 27, 2024

Study Start

February 19, 2025

Primary Completion (Estimated)

August 15, 2029

Study Completion (Estimated)

August 15, 2029

Last Updated

November 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
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.
Access Criteria
Anyone with access to the NCI Cancer Research Data Commons (CRDC)

Locations

US(2)