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NCT Number: NCT06749210

DAANCE FOR CHEMOTHERAPY-INDUCED NEUROPATHY

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tango

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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).

  2. 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),

  3. 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. 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.

  5. 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.

  6. 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

  7. 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".

  8. 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

  9. 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.

  10. Biomechanical measures of postural control

    Time frame: 4 weeks; 8 weeks; 12 weeks

    Postural sway while standing still with eyes closed.

  11. 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)

  12. Gait stability

    Time frame: 4 weeks; 8 weeks

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

  13. 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.

Other outcomes

  1. 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.

  2. 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

  3. Blood-based biomarkers of neurotoxity

    Time frame: 4 weeks (Control group); 8 weeks (Intervention group)

    Neurofilament chains, light density (NfL)

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Worthen-Chaudhari, PhD, MFA, CMES

CONTACT

[email protected]

(1) + 614-293-6281

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Emory University
  • National Institute on Aging (NIA)
  • Yale University

Registry information

Official study title

DANCE-BASED AVENUES TO ADVANCE NONPHARMACOLOGIC TREATMENT OF CHEMOTHERAPY EFFECTS (DAANCE): A MULTICENTER TRIAL

Acronym: DAANCE

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 27, 2024
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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