Clinical trial NCT06749210: DAANCE FOR CHEMOTHERAPY-INDUCED NEUROPATHY
Official title: DANCE-BASED AVENUES TO ADVANCE NONPHARMACOLOGIC TREATMENT OF CHEMOTHERAPY EFFECTS (DAANCE): A MULTICENTER TRIAL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer of the Breast
Chemotherapy-induced Neuropathy
Keywords: survivorship
music
dance
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Yale University
name: Emory University
First posted: 2024-12-27
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient-Reported Outcome (PRO) - CIN sensation
timeFrame: 4 weeks
measure: Dual-task function
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient-Reported Outcome (PRO) - hot/cold sensation
timeFrame: 4 weeks; 8 weeks; 12 weeks
measure: EORTC-CIPN 20
timeFrame: mid-intervention (4weeks); post -intervention (8 weeks); 1 month follow up post intervention
measure: Brief Fatigue Inventory
timeFrame: 4 weeks; 8 weeks; 12 weeks
measure: Brief Pain Inventory
timeFrame: 4 weeks; 8 weeks; 12 weeks
measure: Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: 4 weeks; 8 weeks; 12 weeks
measure: Physical Health Questionnaire-2 (PHQ-2)
timeFrame: 4 weeks; 8 weeks; 12 weeks
measure: Generalized Anxiety Questionnaire
timeFrame: 4 weeks; 8 weeks; 12 weeks
measure: Falls
timeFrame: 4 weeks; 8 weeks; 12 weeks; 6 months following intervention end
measure: The Mini Balance Evaluation Systems Test (MiniBEST)
timeFrame: 4 weeks (Control group); 8 weeks (Intervention group)
measure: Biomechanical measures of postural control
timeFrame: 4 weeks; 8 weeks; 12 weeks
measure: Six minute walk test (6mwt)
timeFrame: 4 weeks; 8 weeks
measure: Gait stability
timeFrame: 4 weeks; 8 weeks
measure: Upper Extremity Function
timeFrame: 4 weeks; 8 weeks; 12 weeks
Other outcomes:
measure: Brain Activity
timeFrame: 4 weeks (Control group); 8 weeks (Intervention group)
measure: Blood-based biomarkers of inflammation
timeFrame: 4 weeks (Control group); 8 weeks (Intervention group)
measure: Blood-based biomarkers of neurotoxity
timeFrame: 4 weeks (Control group); 8 weeks (Intervention group)
measure: Blood-based biomarkers of neuroplasticity
timeFrame: 4 weeks (Control group); 8 weeks (Intervention group)
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Lise B Worthen-Chaudhari, PhD, MFA, CMES
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Maryam B Lustberg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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. 2024 Nov 25:13872877241291440. doi: 10.1177/13872877241291440. Online ahead of print.
citation: 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.
citation: 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.
citation: 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.