Clinical trial NCT05114005: Tango for Neuropathy Among Breast Cancer Survivors
Official title: Novel Interventions for Chemotherapy-Induced Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Breast
Neuropathy
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-11-09
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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).

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);

Primary outcomes:
measure: Postural Control (variability)
timeFrame: 8 weeks
Secondary outcomes:
measure: Postural Control (ellipse area)
timeFrame: 8 weeks
measure: Postural Control (velocity)
timeFrame: 8 weeks
measure: Postural Control (complexity)
timeFrame: 8 weeks
measure: Postural Control (variability)
timeFrame: at the beginning of each assessment or intervention session for up to 20 sessions
measure: Postural Control (variability)
timeFrame: at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
measure: Postural Control (ellipse area)
timeFrame: at the beginning of each assessment or intervention session for up to 20 sessions
measure: Postural Control (ellipse area)
timeFrame: at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
measure: Postural Control (velocity)
timeFrame: at the beginning of each assessment or intervention session for up to 20 sessions
measure: Postural Control (velocity)
timeFrame: at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
measure: Postural Control (complexity)
timeFrame: at the beginning of each assessment or intervention session for up to 20 sessions
measure: Postural Control (complexity)
timeFrame: at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
measure: Postural Control (variability)
timeFrame: 1 month follow up post-intervention
measure: Postural Control (ellipse area)
timeFrame: 1 month follow up post-intervention
measure: Postural Control (velocity)
timeFrame: 1 month follow up post-intervention
measure: Postural Control (complexity)
timeFrame: 1 month follow up post-intervention
measure: Clinical measure of balance function
timeFrame: 8 weeks
measure: Clinical measure of balance function
timeFrame: 1 month follow-up post-intervention
measure: Neuropathy Symptoms Score
timeFrame: at the beginning of each assessment or intervention session for up to 20 sessions
measure: Neuropathy Symptoms Score
timeFrame: at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
measure: Neuropathy Symptoms Score
timeFrame: 8 weeks
measure: Neuropathy Symptoms Score
timeFrame: 1 month follow-up post-intervention
measure: Brief Pain Inventory Short Form
timeFrame: at the beginning of each assessment or intervention session for up to 20 sessions
measure: Brief Pain Inventory Short Form
timeFrame: at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
measure: Brief Pain Inventory Short Form
timeFrame: 8 weeks
measure: Brief Pain Inventory Short Form
timeFrame: 1 month follow-up post-intervention
measure: Cancer-Related Fatigue
timeFrame: at the beginning of each assessment or intervention session for up to 20 sessions
measure: Cancer-Related Fatigue
timeFrame: at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
measure: Cancer-Related Fatigue
timeFrame: 8 weeks
measure: Cancer-Related Fatigue
timeFrame: 1 month follow-up post-intervention
measure: Falls Incidence
timeFrame: once at the point of study enrollment
measure: Falls Incidence
timeFrame: at the beginning of each assessment or intervention session for up to 20 sessions
measure: Falls Incidence
timeFrame: 6 months post-intervention
Other outcomes:
measure: Quantified Clinical Measure of Balance Function
timeFrame: 8 weeks
measure: Quantified Clinical Measure of Balance Function
timeFrame: 1 month follow-up post-intervention
Locations:
city: Columbus
country: United States
facility: Stephanie Spielman Comprehensive Breast Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Lise Worthen-Chaudhari, PhD, MFA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hackney ME, Earhart GM. Recommendations for Implementing Tango Classes for Persons with Parkinson Disease. Am J Dance Ther. 2010 Jun;32(1):41-52. doi: 10.1007/s10465-010-9086-y.
citation: Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.