AzTrials
AzTrials

Cancer of the BreastPhase 2DAANCENCT06749210

DAANCE FOR CHEMOTHERAPY-INDUCED NEUROPATHY

A Phase 2 study testing Tango in people with Cancer of the Breast and Chemotherapy-induced Neuropathy, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Tango
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
2 sitesUnited States
Study dates
19 Feb 2025to 15 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 (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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lise Worthen-Chaudhari, PhD, MFA, CMES contact

(1) + 614-293-6281

lise.worthen-chaudhari@osumc.edu

United States2 sites, 2 recruiting

  • The Ohio State University

    Columbus, Ohio, 43220

    Lise Worthen-Chaudhari, PhD, MFA, CMES, (1) + 614-293-6281, lise.worthen-chaudhari@osumc.edu

    Lise Worthen-Chaudhari, PhD, MFA, CMES

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Maryam Lustberg, MD, MPH, maryam.lustberg@yale.edu

    Maryam Lustberg, MD, MPH

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Tango
Keywords
survivorship, music, dance
Medical subject headings
Breast Neoplasms

What participants receive

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

  • TangoBehavioural

    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.

Study groups in NCT06749210
Study groupRoleWhat they receive
ControlNo intervention4 weeks of usual care followed by optional 1-way crossover to 8 weeks of Intervention (partnered, adapted tango dance)
ExperimentalExperimental8 weeks of intervention (partnered, adapted tango dance)
Receives: Behavioral: Tango

What is being measured

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

  1. 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)

    Measured: 4 weeks

  2. 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)

    Measured: 4 weeks

Secondary outcomes (13)

  1. Patient-Reported Outcome (PRO) - hot/cold sensation

    Sensation of hot and/or cold (11 point Likert scale).

    Measured: 4 weeks; 8 weeks; 12 weeks

  2. EORTC-CIPN 20

    European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy symptoms inventory (CIPN 20),

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

  3. Brief Fatigue Inventory

    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.

    Measured: 4 weeks; 8 weeks; 12 weeks

  4. Brief Pain Inventory

    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.

    Measured: 4 weeks; 8 weeks; 12 weeks

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

    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.

    Measured: 4 weeks; 8 weeks; 12 weeks

  6. Physical Health Questionnaire-2 (PHQ-2)

    The PHQ-2 asks how often a patient has experienced depressed mood or anhedonia in the last two weeks

    Measured: 4 weeks; 8 weeks; 12 weeks

  7. Generalized Anxiety Questionnaire

    Each question has a 4-point scale, ranging from 1, "not at all", to 4, "nearly every day".

    Measured: 4 weeks; 8 weeks; 12 weeks

  8. Falls

    Report of whether you have fallen or lost your balanced since we last spoke with you

    Measured: 4 weeks; 8 weeks; 12 weeks; 6 months following intervention end

  9. The Mini Balance Evaluation Systems Test (MiniBEST)

    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.

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

  10. Biomechanical measures of postural control

    Postural sway while standing still with eyes closed.

    Measured: 4 weeks; 8 weeks; 12 weeks

  11. Six minute walk test (6mwt)

    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)

    Measured: 4 weeks; 8 weeks

  12. Gait stability

    Stability between gait strides over the period of the 6mwt.

    Measured: 4 weeks; 8 weeks

  13. Upper Extremity Function

    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.

    Measured: 4 weeks; 8 weeks; 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 posted27 Dec 2024
  2. Study start19 Feb 2025
  3. Primary completion15 Aug 2029 (estimated)
  4. Study completion15 Aug 2029 (estimated)

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06749210
Sponsor's protocol ID
OSU-24277
Other IDs
R01AG084676, OSU-24277
Acronym
DAANCE
Status last verified
Oct 2026
First submitted
17 Dec 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 24139684

  • 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

  • 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.

    PubMed 39584292

  • 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.

    PubMed 31751861

  • 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.

    PubMed 29908434

  • 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.

    PubMed 35167004

  • Luciani BD, Alwan A, 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. Trials. 2026 Feb 21;27(1):246. doi: 10.1186/s13063-026-09486-w.

    PubMed 41723535

  • 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.

    PubMed 40671809

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tango in people with Cancer of the Breast and Chemotherapy-induced Neuropathy, run by Ohio State University Comprehensive Cancer Center at 2 sites 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Lise Worthen-Chaudhari, PhD, MFA, CMES ((1) + 614-293-6281, lise.worthen-chaudhari@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-Reported Outcome (PRO) - CIN sensation (time frame: 4 weeks). 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 NCT06749210, which also lists 8 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 9 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in