Breast Cancer Clinical Trial

Tango for Neuropathy Among Breast Cancer Survivors

Summary

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.

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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).

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Eligibility Criteria

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);

Study is for people with:

Breast Cancer

Estimated Enrollment:

52

Study ID:

NCT05114005

Recruitment Status:

Recruiting

Sponsor:

Ohio State University Comprehensive Cancer Center

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There is 1 Location for this study

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Stephanie Spielman Comprehensive Breast Center
Columbus Ohio, 43212, United States More Info
Lise C Worthen-Chaudhari, PhD, MFA
Contact
614-293-6281
[email protected]

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Study is for people with:

Breast Cancer

Estimated Enrollment:

52

Study ID:

NCT05114005

Recruitment Status:

Recruiting

Sponsor:


Ohio State University Comprehensive Cancer Center

How clear is this clinincal trial information?

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