Tango for Neuropathy Among Breast Cancer Survivors

Neuropathy Clinical Trial

Official title:

Novel Interventions for Chemotherapy-Induced Neuropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05114005
• Other study ID #: 2015C0090
• Secondary ID: NCI-2018-00310R2
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: August 14, 2024

Study information

• Verified date: September 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: August 14, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast
• Neuropathy

Intervention

Behavioral:
• Rhythmic Auditory Stimulation
Rhythmically-entrained sensorimotor activity.
• Evidence-Based Exercise
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

Locations

Country	Name	City	State
United States	Stephanie Spielman Comprehensive Breast Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantified Clinical Measure of Balance Function	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	8 weeks
Other	Quantified Clinical Measure of Balance Function	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.	1 month follow-up post-intervention
Primary	Postural Control (variability)	root-mean square of the center of pressure (COP)	8 weeks
Secondary	Postural Control (ellipse area)	95% ellipse area of the COP	8 weeks
Secondary	Postural Control (velocity)	velocity of COP	8 weeks
Secondary	Postural Control (complexity)	sample entropy of COP	8 weeks
Secondary	Postural Control (variability)	root-mean square of the center of pressure (COP)	at the beginning of each assessment or intervention session for up to 20 sessions
Secondary	Postural Control (variability)	root-mean square of the center of pressure (COP)	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Secondary	Postural Control (ellipse area)	95% ellipse area of the COP	at the beginning of each assessment or intervention session for up to 20 sessions
Secondary	Postural Control (ellipse area)	95% ellipse area of the COP	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Secondary	Postural Control (velocity)	velocity of COP	at the beginning of each assessment or intervention session for up to 20 sessions
Secondary	Postural Control (velocity)	velocity of COP	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Secondary	Postural Control (complexity)	sample entropy of COP	at the beginning of each assessment or intervention session for up to 20 sessions
Secondary	Postural Control (complexity)	sample entropy of COP	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Secondary	Postural Control (variability)	root-mean square of the center of pressure (COP)	1 month follow up post-intervention
Secondary	Postural Control (ellipse area)	95% ellipse area of the COP	1 month follow up post-intervention
Secondary	Postural Control (velocity)	velocity of COP	1 month follow up post-intervention
Secondary	Postural Control (complexity)	sample entropy of COP	1 month follow up post-intervention
Secondary	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.	8 weeks
Secondary	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.	1 month follow-up post-intervention
Secondary	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.	at the beginning of each assessment or intervention session for up to 20 sessions
Secondary	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.	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Secondary	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.	8 weeks
Secondary	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.	1 month follow-up post-intervention
Secondary	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).	at the beginning of each assessment or intervention session for up to 20 sessions
Secondary	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).	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Secondary	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).	8 weeks
Secondary	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).	1 month follow-up post-intervention
Secondary	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).	at the beginning of each assessment or intervention session for up to 20 sessions
Secondary	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).	at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions
Secondary	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).	8 weeks
Secondary	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).	1 month follow-up post-intervention
Secondary	Falls Incidence	the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study	once at the point of study enrollment
Secondary	Falls Incidence	the number of falls or near falls experienced by the participant since last evaluation/intervention session	at the beginning of each assessment or intervention session for up to 20 sessions
Secondary	Falls Incidence	the number of falls or near falls experienced by the participant in the 6 months post-intervention	6 months post-intervention