DAANCE for CHEMOTHERAPY-INDUCED NEUROPATHY

Phase 2

Recruiting

• Conditions: Cancer of the Breast; Chemotherapy-induced Neuropathy

• Registration Number: NCT06749210
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Study Start: 2025-02-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcome (PRO) - CIN sensation	4 weeks	Sensation of numbness/tingling on 0-10 scale; minimum value 0 (no numbness/tingling); maximum value 10 (worst numbness/tingling)
Dual-task function	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 Outcome Measures

Name	Time	Method
Patient-Reported Outcome (PRO) - hot/cold sensation	4 weeks; 8 weeks; 12 weeks	Sensation of hot and/or cold (11 point Likert scale).
EORTC-CIPN 20	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),
Brief Fatigue Inventory	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.
Brief Pain Inventory	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.
Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	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.
Physical Health Questionnaire-2 (PHQ-2)	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
Generalized Anxiety Questionnaire	4 weeks; 8 weeks; 12 weeks	Each question has a 4-point scale, ranging from 1, "not at all", to 4, "nearly every day".
Falls	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
The Mini Balance Evaluation Systems Test (MiniBEST)	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.
Biomechanical measures of postural control	4 weeks; 8 weeks; 12 weeks	Postural sway while standing still with eyes closed.
Six minute walk test (6mwt)	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)
Gait stability	4 weeks; 8 weeks	Stability between gait strides over the period of the 6mwt.
Upper Extremity Function	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.

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States