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Tango for Neuropathy Among Breast Cancer Survivors

Primary Purpose

Cancer, Breast, Neuropathy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rhythmic Auditory Stimulation
Evidence-Based Exercise
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Breast

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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);

Sites / Locations

  • Stephanie Spielman Comprehensive Breast Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tango

Home Exercise (HEX)

Arm 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.

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 hr training (i.e., endurance, resistance, and sensorimotor) performed 2x per week

Outcomes

Primary Outcome Measures

Postural Control (variability)
root-mean square of the center of pressure (COP)

Secondary Outcome Measures

Postural Control (ellipse area)
95% ellipse area of the COP
Postural Control (velocity)
velocity of COP
Postural Control (complexity)
sample entropy of COP
Postural Control (variability)
root-mean square of the center of pressure (COP)
Postural Control (variability)
root-mean square of the center of pressure (COP)
Postural Control (ellipse area)
95% ellipse area of the COP
Postural Control (ellipse area)
95% ellipse area of the COP
Postural Control (velocity)
velocity of COP
Postural Control (velocity)
velocity of COP
Postural Control (complexity)
sample entropy of COP
Postural Control (complexity)
sample entropy of COP
Postural Control (variability)
root-mean square of the center of pressure (COP)
Postural Control (ellipse area)
95% ellipse area of the COP
Postural Control (velocity)
velocity of COP
Postural Control (complexity)
sample entropy of COP
Clinical measure of balance function
The Timed Up-and-Go test, or TUG, (<2 min to administer) is a timed test of a person's ability to stand from a chair, walk 10 feet, turn around, and return to sitting with shorter times indicating better functional balance.
Clinical measure of balance function
The Timed Up-and-Go test, or TUG, (<2 min to administer) is a timed test of a person's ability to stand from a chair, walk 10 feet, turn around, and return to sitting with shorter times indicating better functional balance.
Neuropathy Symptoms Score
European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.
Neuropathy Symptoms Score
European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.
Neuropathy Symptoms Score
European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.
Neuropathy Symptoms Score
European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.
Brief Pain Inventory Short Form
The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).
Brief Pain Inventory Short Form
The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).
Brief Pain Inventory Short Form
The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).
Brief Pain Inventory Short Form
The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).
Cancer-Related Fatigue
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).
Cancer-Related Fatigue
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).
Cancer-Related Fatigue
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).
Cancer-Related Fatigue
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).
Falls Incidence
the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study
Falls Incidence
the number of falls or near falls experienced by the participant since last evaluation/intervention session
Falls Incidence
the number of falls or near falls experienced by the participant in the 6 months post-intervention

Full Information

First Posted
September 20, 2021
Last Updated
September 19, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05114005
Brief Title
Tango for Neuropathy Among Breast Cancer Survivors
Official Title
Novel Interventions for Chemotherapy-Induced Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
August 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Neuropathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tango
Arm Type
Experimental
Arm 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.
Arm Title
Home Exercise (HEX)
Arm Type
Active Comparator
Arm 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 hr training (i.e., endurance, resistance, and sensorimotor) performed 2x per week
Intervention Type
Behavioral
Intervention Name(s)
Rhythmic Auditory Stimulation
Intervention Description
Rhythmically-entrained sensorimotor activity.
Intervention Type
Behavioral
Intervention Name(s)
Evidence-Based Exercise
Intervention Description
This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hr training (i.e., endurance, resistance, and sensorimotor) performed 2x per week
Primary Outcome Measure Information:
Title
Postural Control (variability)
Description
root-mean square of the center of pressure (COP)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Postural Control (ellipse area)
Description
95% ellipse area of the COP
Time Frame
8 weeks
Title
Postural Control (velocity)
Description
velocity of COP
Time Frame
8 weeks
Title
Postural Control (complexity)
Description
sample entropy of COP
Time Frame
8 weeks
Title
Postural Control (variability)
Description
root-mean square of the center of pressure (COP)
Time Frame
at the beginning of each assessment or intervention session for up to 20 sessions
Title
Postural Control (variability)
Description
root-mean square of the center of pressure (COP)
Time Frame
at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Title
Postural Control (ellipse area)
Description
95% ellipse area of the COP
Time Frame
at the beginning of each assessment or intervention session for up to 20 sessions
Title
Postural Control (ellipse area)
Description
95% ellipse area of the COP
Time Frame
at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Title
Postural Control (velocity)
Description
velocity of COP
Time Frame
at the beginning of each assessment or intervention session for up to 20 sessions
Title
Postural Control (velocity)
Description
velocity of COP
Time Frame
at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Title
Postural Control (complexity)
Description
sample entropy of COP
Time Frame
at the beginning of each assessment or intervention session for up to 20 sessions
Title
Postural Control (complexity)
Description
sample entropy of COP
Time Frame
at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Title
Postural Control (variability)
Description
root-mean square of the center of pressure (COP)
Time Frame
1 month follow up post-intervention
Title
Postural Control (ellipse area)
Description
95% ellipse area of the COP
Time Frame
1 month follow up post-intervention
Title
Postural Control (velocity)
Description
velocity of COP
Time Frame
1 month follow up post-intervention
Title
Postural Control (complexity)
Description
sample entropy of COP
Time Frame
1 month follow up post-intervention
Title
Clinical measure of balance function
Description
The Timed Up-and-Go test, or TUG, (<2 min to administer) is a timed test of a person's ability to stand from a chair, walk 10 feet, turn around, and return to sitting with shorter times indicating better functional balance.
Time Frame
8 weeks
Title
Clinical measure of balance function
Description
The Timed Up-and-Go test, or TUG, (<2 min to administer) is a timed test of a person's ability to stand from a chair, walk 10 feet, turn around, and return to sitting with shorter times indicating better functional balance.
Time Frame
1 month follow-up post-intervention
Title
Neuropathy Symptoms Score
Description
European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.
Time Frame
at the beginning of each assessment or intervention session for up to 20 sessions
Title
Neuropathy Symptoms Score
Description
European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.
Time Frame
at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Title
Neuropathy Symptoms Score
Description
European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.
Time Frame
8 weeks
Title
Neuropathy Symptoms Score
Description
European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.
Time Frame
1 month follow-up post-intervention
Title
Brief Pain Inventory Short Form
Description
The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).
Time Frame
at the beginning of each assessment or intervention session for up to 20 sessions
Title
Brief Pain Inventory Short Form
Description
The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).
Time Frame
at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Title
Brief Pain Inventory Short Form
Description
The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).
Time Frame
8 weeks
Title
Brief Pain Inventory Short Form
Description
The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).
Time Frame
1 month follow-up post-intervention
Title
Cancer-Related Fatigue
Description
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).
Time Frame
at the beginning of each assessment or intervention session for up to 20 sessions
Title
Cancer-Related Fatigue
Description
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).
Time Frame
at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Title
Cancer-Related Fatigue
Description
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).
Time Frame
8 weeks
Title
Cancer-Related Fatigue
Description
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).
Time Frame
1 month follow-up post-intervention
Title
Falls Incidence
Description
the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study
Time Frame
once at the point of study enrollment
Title
Falls Incidence
Description
the number of falls or near falls experienced by the participant since last evaluation/intervention session
Time Frame
at the beginning of each assessment or intervention session for up to 20 sessions
Title
Falls Incidence
Description
the number of falls or near falls experienced by the participant in the 6 months post-intervention
Time Frame
6 months post-intervention
Other Pre-specified Outcome Measures:
Title
Quantified Clinical Measure of Balance Function
Description
The Mini Balance Evaluation System Test short version (MiniBEST): evaluates sensory organization, anticipatory and reactive postural control, and dynamic gait indices on a scale from 1 to 28 points (28 represents the highest function measurable by the test); was recently recommended for use in studies of neuropathy; and discriminated BC survivors from controls in at least 1 prior study. Instrumentation of MiniBEST will enable the calculation of spatiotemporal, kinematic, and co-contraction measures
Time Frame
8 weeks
Title
Quantified Clinical Measure of Balance Function
Description
The Mini Balance Evaluation System Test short version (MiniBEST): evaluates sensory organization, anticipatory and reactive postural control, and dynamic gait indices on a scale from 1 to 28 points (28 represents the highest function measurable by the test); was recently recommended for use in studies of neuropathy; and discriminated BC survivors from controls in at least 1 prior study. Instrumentation of MiniBEST will enable the calculation of spatiotemporal, kinematic, and co-contraction measures.
Time Frame
1 month follow-up post-intervention

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise Worthen-Chaudhari, PhD, MFA
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephanie Spielman Comprehensive Breast Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30369677
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.
Results Reference
background
PubMed Identifier
28963591
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.
Results Reference
background

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Tango for Neuropathy Among Breast Cancer Survivors

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