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DAANCE FOR CHEMOTHERAPY-INDUCED NEUROPATHY

The Ohio State University logo

The Ohio State University

Status and phase

Enrolling
Phase 2

Conditions

Cancer of the Breast
Chemotherapy-induced Neuropathy

Treatments

Behavioral: Tango

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06749210
OSU-24277 (Other Identifier)
R01AG084676 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Control
No Intervention group
Description:
4 weeks of usual care followed by optional 1-way crossover to 8 weeks of Intervention (partnered, adapted tango dance)
Experimental
Experimental group
Description:
8 weeks of intervention (partnered, adapted tango dance)
Treatment:
Behavioral: Tango

Trial contacts and locations

2

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Central trial contact

Lise Worthen-Chaudhari, PhD, MFA, CMES

Data sourced from clinicaltrials.gov

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