Tango for Neuropathy Among Breast Cancer Survivors

The Ohio State University

Status: Completed

Conditions: Cancer, Breast; Neuropathy

Treatments: Behavioral: Evidence-Based Exercise; Behavioral: Rhythmic Auditory Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05114005

R21AG068831 (U.S. NIH Grant/Contract)

2015C0090

NCI-2018-00310 (Registry Identifier)

OSU-15047 (Other Identifier)

Details and patient eligibility

About

Group dance classes have been found to improve markers of quality of life and physical health (i.e., balance) among some populations engaged in rehabilitation, such as the elderly and individuals with Parkinson Disease. However, such interventions have yet to be studied among cancer survivors despite the relevance of quality of life and physical health within cancer survivorship. Group dance classes are a promising avenue in that they deliver activity-based medicine in a social context, thus potentially improving physical as well as psychosocial aspects of health. To further this avenue of inquiry, we propose to study the effect of dance-based interventions for cancer survivors.

Full description

Participants will be randomized (1:1) to one of two activity intervention arms: Argentine Tango dance or home exercise. Information about neuropathy symptoms, motion, falls incidence, and participant feedback about the interventions will be collected.

Aim1: To evaluate change in postural control over 16 sessions of Tango (exp) vs HEX (control) (n=26 per group) as primary endpoint. As secondary measures, to assess: balance function (i.e., TUG) and patient-reported outcomes (PROs) (i.e., symptoms, pain, fatigue, mood, quality of life) monthly including 1 month post-intervention completion; postural control and symptoms within-session; and falls incidence weekly for 6 months following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures sensitive to neuropathy disease state (i.e., sway variability and area).

Aim2: To evaluate change in gait variability after 16 sessions of Tango (exp) vs HEX (control) (n=26 per group; 1:1 randomization). As secondary measures, to analyze local and orbital dynamic stability (pre, post, and 1mo post-intervention), PROs (monthly), and falls incidence (weekly) following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures of gait variability (i.e., stride-to-stride variability in speed).

Enrollment: 52 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer survivor stage I-III
• Symptomatic for neuropathy
• postural control outside 70% CI for adults who are middle-aged without neurotrauma
• having completed taxane-based chemotherapy treatment at least 3 months ago;
• able to understand and comply with directions associated with testing and study treatments.

Exclusion criteria

• Pre-existing vestibular deficit;
• poorly controlled diabetes (hgA1C > 8);
• non-ambulatory or lower extremity amputation (assistive devices allowed);
• use of cytotoxic or immunotherapy during study (endocrine therapy allowed);
• participation in physical therapy during the study;
• contraindication to participate in Tango due to orthopedic issue (e.g., herniated vertebral disc);

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Tango

Experimental group

Description:

The intervention will consist of 16 Argentine Tango (Tango) sessions, adapted for neurorehabilitation per Hackney and Earhart (2010). Delivered over 8 weeks at a frequency of 2x per week and duration of 1 hour per session, this program teaches the basics steps of partnered Tango dance.

Treatment:

Behavioral: Rhythmic Auditory Stimulation

Home Exercise (HEX)

Active Comparator group

Description:

The control group will consist of an evidence-based, structured home exercise program (HEX) based on the 8 week intervention described by Zimmer et al (2018) and recommended by physical therapists specializing in BC within our organization. This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hour training (i.e., endurance, resistance, and sensorimotor) performed 2x per week

Treatment:

Behavioral: Evidence-Based Exercise