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Tango for Neuropathy Among Breast Cancer Survivors

Dance-Based Avenues to Advance Nonpharmacologic Treatment of Chemotherapy Effects (DAANCE)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05114005
Enrollment
52
Registered
2021-11-09
Start date
2021-08-15
Completion date
2024-04-15
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Breast, Neuropathy

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).

Interventions

Rhythmically-entrained sensorimotor activity.

BEHAVIORALEvidence-Based Exercise

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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);

Design outcomes

Primary

MeasureTime frameDescription
Intrinsic MotivationAssessed at week 4, week 8, and week 12Intrinsic motivation will be measured using a subscale of the Intrinsic Motivation Inventory (IMI). The 6 item Interest/Enjoyment subscale of the IMI represents intrinsic motivation in an activity just performed as a possible score of 6 to 36 with 6 = most; 18 = neutral; 36 = least interesting/enjoyable. Specific items queried include whether the activity just performed was: enjoyable, enjoyed, boring (reverse order), interesting, fun, and able to hold the participant's attention.
Postural Control (Variability)At baseline, week 8 of intervention, and at 4 week follow-up post interventionroot-mean square of the center of pressure (COP)

Secondary

MeasureTime frameDescription
Postural Control (Velocity)At baseline, week 8 of intervention, and at 4 week follow-up post interventionvelocity of COP
Postural Control (Complexity)At baseline, week 8 of intervention, and at 4 week follow-up post interventionsample entropy of the center of pressure (COP). Sample entropy is a non-linear COP measure that determines the irregularity of a time-series. Sample entropy of the resultant COP position will be calculated using the increment calculation method (SEI) with constant values applied of m = 3 and r = 0.3. Entropy of postural responses represents the automatic complexity of neuromotor control that is available to an individual. Sample entropy scores won't go below 0 or above 2, and higher values indicate better complexity in postural response
Postural Control (Variability) at Tango Sessionsat the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeksroot-mean square of the center of pressure (COP). The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.
Postural Control (Ellipse Area) at Tango Sessionsat the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks95% ellipse area of the COP. The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.
Postural Control (Velocity) at Tango Sessionsat the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeksvelocity of COP. The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.
Postural Control (Complexity) at Tango Sessionsat the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weekssample entropy of the center of pressure (COP). Sample entropy is a non-linear COP measure that determines the irregularity of a time-series. Sample entropy of the resultant COP position will be calculated using the increment calculation method (SEI) with constant values applied of m = 3 and r = 0.3. Entropy of postural responses represents the automatic complexity of neuromotor control that is available to an individual. Sample entropy scores won't go below 0 or above 2, and higher values indicate better complexity in postural responseThe mean will be taken of all beginning of session data points together and all end of session data points together
Clinical Measure of Balance FunctionAt baseline, week 4 of intervention, and at 4 week follow-up post intervention, up to 12 weeksThe 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 at Tango Sessionsat the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeksEuropean 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. It is easy to use and filled out by patients themselves. Scores range between 1 to 10 with higher scores indicating greater chemotherapy-induced peripheral neuropathy (CIPN) severity. The mean will be taken of all beginning of session data points together and all end of session data points together
Brief Pain Inventory Short Form at Tango Sessionsat the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeksThe 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). The mean will be taken of all beginning of session data points together and all end of session data points together
Brief Pain Inventory Short FormAt week 8 of intervention and at 4-week follow-up post interventionThe 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 (BFI Scores) at Tango Sessionsat the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeksThe 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). The mean will be taken of all beginning of session data points together and all end of session data points together
Cancer-Related FatigueAt week 8 and at 4-week follow-up visit post interventionThe 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).
Number of Fallsonce at the point of study enrollmentthe number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study will be assessed. All reported falls will be totaled and reported by arm.
Change in Dual-task FunctionAssessed at baseline, 4 weeks, 8 weeks, and 12 weeksDual task function was measured using the Timed-Up-and-Go motor task while counting backward by 3 s (TUGCog), a validated clinical test of dual-task function for which lower values indicate better performance. To perform this test, participants completed the Timed-Up-and Go (TUG) test commonly used in clinical practice wherein individuals stand from a chair with arms, walk 3 meters, turn around, and return to sitting as fast as safely possible (i.e. motor task) while counting out loud and backward by 3 s (i.e. cognitive task). The test is completed 3 times, with rest allowed between trials. Time in seconds per trial is averaged to produce the TUGCog score per timepoint.
AdherenceAssessed at baseline, 4 weeks, 8 weeks, and 12 weeksAdherence is measured by the number of enrollees who participated through each time point of the study
Neuropathy Symptoms ScoreAt week 8 of intervention and at 4-week follow-up post interventionEuropean 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. It is easy to use and filled out by patients themselves. Scores range between 1 to 10 with higher scores indicating greater chemotherapy-induced peripheral neuropathy (CIPN) severity.
Postural Control (Ellipse Area)At baseline, week 8 of intervention, and at 4 week follow-up post intervention95% ellipse area of the COP

Other

MeasureTime frameDescription
Quantified Clinical Measure of Balance Function8 weeksThe 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Tango
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. Rhythmic Auditory Stimulation: Rhythmically-entrained sensorimotor activity.
26
Home Exercise (HEX)
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 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
26
Total52

Baseline characteristics

CharacteristicTangoTotalHome Exercise (HEX)
Age, Continuous63.6 years
STANDARD_DEVIATION 8.37
61.2 years
STANDARD_DEVIATION 9.65
58.9 years
STANDARD_DEVIATION 10.4
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants52 Participants26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants3 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
23 Participants48 Participants25 Participants
Region of Enrollment
United States
26 participants52 participants26 participants
Sex: Female, Male
Female
25 Participants51 Participants26 Participants
Sex: Female, Male
Male
1 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 260 / 26
other
Total, other adverse events
19 / 2611 / 26
serious
Total, serious adverse events
1 / 262 / 26

Outcome results

Primary

Intrinsic Motivation

Intrinsic motivation will be measured using a subscale of the Intrinsic Motivation Inventory (IMI). The 6 item Interest/Enjoyment subscale of the IMI represents intrinsic motivation in an activity just performed as a possible score of 6 to 36 with 6 = most; 18 = neutral; 36 = least interesting/enjoyable. Specific items queried include whether the activity just performed was: enjoyable, enjoyed, boring (reverse order), interesting, fun, and able to hold the participant's attention.

Time frame: Assessed at week 4, week 8, and week 12

Population: The number of analyzed participants is the number of participants who were still adhering to the study intervention at the time points that intrinsic motivation data was collected

ArmMeasureGroupValue (MEDIAN)
TangoIntrinsic Motivation4 weeks6 score on a scale
TangoIntrinsic Motivation8 weeks6 score on a scale
TangoIntrinsic Motivation12 weeks6 score on a scale
Home Exercise (HEX)Intrinsic Motivation4 weeks21.5 score on a scale
Home Exercise (HEX)Intrinsic Motivation8 weeks18 score on a scale
Home Exercise (HEX)Intrinsic Motivation12 weeks16 score on a scale
Primary

Postural Control (Variability)

root-mean square of the center of pressure (COP)

Time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention

Population: The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
TangoPostural Control (Variability)Baseline10.3 millimetersStandard Deviation 4.93
TangoPostural Control (Variability)Week 88.03 millimetersStandard Deviation 3.54
TangoPostural Control (Variability)Follow-up Visit (4 weeks post-intervention)7.74 millimetersStandard Deviation 3.67
Home Exercise (HEX)Postural Control (Variability)Baseline9.64 millimetersStandard Deviation 2.42
Home Exercise (HEX)Postural Control (Variability)Week 88.00 millimetersStandard Deviation 2.82
Home Exercise (HEX)Postural Control (Variability)Follow-up Visit (4 weeks post-intervention)8.61 millimetersStandard Deviation 2.31
Secondary

Adherence

Adherence is measured by the number of enrollees who participated through each time point of the study

Time frame: Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks

ArmMeasureGroupValue (NUMBER)
TangoAdherenceAttended Introductory Session23 participants
TangoAdherenceAdhered through 8 weeks of intervention17 participants
TangoAdherenceAdhered through 4 weeks of intervention20 participants
TangoAdherenceReturned for follow-up 1 month post- intervention (12 week timepoint)17 participants
TangoAdherenceRandomized26 participants
Home Exercise (HEX)AdherenceReturned for follow-up 1 month post- intervention (12 week timepoint)8 participants
Home Exercise (HEX)AdherenceRandomized26 participants
Home Exercise (HEX)AdherenceAttended Introductory Session22 participants
Home Exercise (HEX)AdherenceAdhered through 4 weeks of intervention13 participants
Home Exercise (HEX)AdherenceAdhered through 8 weeks of intervention10 participants
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).

Time frame: At week 8 of intervention and at 4-week follow-up post intervention

Population: The number of participants analyzed is the number of participants for which BPI scores were collected at each time point

ArmMeasureGroupValue (MEAN)Dispersion
TangoBrief Pain Inventory Short FormWeek 81.72 score on a scaleStandard Deviation 1.53
TangoBrief Pain Inventory Short FormFollow-up (4 weeks post-intervention)1.78 score on a scaleStandard Deviation 1.83
Home Exercise (HEX)Brief Pain Inventory Short FormWeek 81.07 score on a scaleStandard Deviation 0.999
Home Exercise (HEX)Brief Pain Inventory Short FormFollow-up (4 weeks post-intervention)1.55 score on a scaleStandard Deviation 1.99
Secondary

Brief Pain Inventory Short Form at Tango Sessions

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). The mean will be taken of all beginning of session data points together and all end of session data points together

Time frame: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

Population: BPI scores at Tango sessions were only measured for participants in the Tango arm.

ArmMeasureGroupValue (MEAN)Dispersion
TangoBrief Pain Inventory Short Form at Tango SessionsBeginning of sessions1.68 score on a scaleStandard Deviation 1.59
TangoBrief Pain Inventory Short Form at Tango SessionsEnd of sessions1.20 score on a scaleStandard Deviation 1.28
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).

Time frame: At week 8 and at 4-week follow-up visit post intervention

Population: The number of participants analyzed is the number of participants for which BFI scores were collected at each time point

ArmMeasureGroupValue (MEAN)Dispersion
TangoCancer-Related FatigueWeek 88.13 score on a scaleStandard Deviation 8.95
TangoCancer-Related FatigueFollow-up (4 weeks post intervention)7.22 score on a scaleStandard Deviation 8.72
Home Exercise (HEX)Cancer-Related FatigueWeek 810.7 score on a scaleStandard Deviation 11.4
Home Exercise (HEX)Cancer-Related FatigueFollow-up (4 weeks post intervention)13.3 score on a scaleStandard Deviation 14.3
Secondary

Cancer-Related Fatigue (BFI Scores) at Tango Sessions

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). The mean will be taken of all beginning of session data points together and all end of session data points together

Time frame: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

Population: BFI scores at Tango sessions were only measured for participants in the Tango arm.

ArmMeasureGroupValue (MEAN)Dispersion
TangoCancer-Related Fatigue (BFI Scores) at Tango SessionsBeginning of sessions8.56 score on a scaleStandard Deviation 9.61
TangoCancer-Related Fatigue (BFI Scores) at Tango SessionsEnd of sessions1.21 score on a scaleStandard Deviation 1.3
Secondary

Change in Dual-task Function

Dual task function was measured using the Timed-Up-and-Go motor task while counting backward by 3 s (TUGCog), a validated clinical test of dual-task function for which lower values indicate better performance. To perform this test, participants completed the Timed-Up-and Go (TUG) test commonly used in clinical practice wherein individuals stand from a chair with arms, walk 3 meters, turn around, and return to sitting as fast as safely possible (i.e. motor task) while counting out loud and backward by 3 s (i.e. cognitive task). The test is completed 3 times, with rest allowed between trials. Time in seconds per trial is averaged to produce the TUGCog score per timepoint.

Time frame: Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks

ArmMeasureGroupValue (MEAN)
TangoChange in Dual-task FunctionChange between baseline to 4 weeks-2.65 seconds
TangoChange in Dual-task FunctionChange between baseline and 8 weeks-2.47 seconds
TangoChange in Dual-task FunctionChange between baseline and 12 weeks (follow-up visit)-2.68 seconds
Home Exercise (HEX)Change in Dual-task FunctionChange between baseline to 4 weeks-1.9 seconds
Home Exercise (HEX)Change in Dual-task FunctionChange between baseline and 8 weeks-2.65 seconds
Home Exercise (HEX)Change in Dual-task FunctionChange between baseline and 12 weeks (follow-up visit)-3.06 seconds
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.

Time frame: At baseline, week 4 of intervention, and at 4 week follow-up post intervention, up to 12 weeks

Population: The number of participants analyzed represents the number who completed the TUG tests at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
TangoClinical Measure of Balance FunctionBaseline10.3 secondsStandard Deviation 2.47
TangoClinical Measure of Balance FunctionWeek 48.65 secondsStandard Deviation 1.92
TangoClinical Measure of Balance FunctionFollow-up Visit (4 weeks post-intervention)8.49 secondsStandard Deviation 1.79
Home Exercise (HEX)Clinical Measure of Balance FunctionBaseline11.7 secondsStandard Deviation 5.21
Home Exercise (HEX)Clinical Measure of Balance FunctionWeek 48.25 secondsStandard Deviation 1.74
Home Exercise (HEX)Clinical Measure of Balance FunctionFollow-up Visit (4 weeks post-intervention)7.70 secondsStandard Deviation 1.25
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. It is easy to use and filled out by patients themselves. Scores range between 1 to 10 with higher scores indicating greater chemotherapy-induced peripheral neuropathy (CIPN) severity.

Time frame: At week 8 of intervention and at 4-week follow-up post intervention

Population: The number of participants analyzed is the number of participants for which neuropathy symptoms scores were collected at each time point

ArmMeasureGroupValue (MEAN)Dispersion
TangoNeuropathy Symptoms ScoreWeek 86.60 score on a scaleStandard Deviation 3.97
TangoNeuropathy Symptoms ScoreFollow-up (4 weeks post-intervention)7.06 score on a scaleStandard Deviation 4.08
Home Exercise (HEX)Neuropathy Symptoms ScoreWeek 86.89 score on a scaleStandard Deviation 7.41
Home Exercise (HEX)Neuropathy Symptoms ScoreFollow-up (4 weeks post-intervention)5.18 score on a scaleStandard Deviation 5.36
Secondary

Neuropathy Symptoms Score at Tango Sessions

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. It is easy to use and filled out by patients themselves. Scores range between 1 to 10 with higher scores indicating greater chemotherapy-induced peripheral neuropathy (CIPN) severity. The mean will be taken of all beginning of session data points together and all end of session data points together

Time frame: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

Population: Neuropathy symptoms scores at Tango sessions were only measured for participants in the Tango arm.

ArmMeasureGroupValue (MEAN)Dispersion
TangoNeuropathy Symptoms Score at Tango SessionsBeginning of sessions6.68 score on a scaleStandard Deviation 4.25
TangoNeuropathy Symptoms Score at Tango SessionsEnd of sessions3.29 score on a scaleStandard Deviation 3.01
Secondary

Number of Falls

the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study will be assessed. All reported falls will be totaled and reported by arm.

Time frame: once at the point of study enrollment

ArmMeasureValue (NUMBER)
TangoNumber of Falls1 number of falls
Home Exercise (HEX)Number of Falls0 number of falls
Secondary

Number of Falls

the number of falls or near falls experienced by the participant since last evaluation/intervention session. All reported falls throughout the intervention time period will be totaled and reported by arm.

Time frame: at the beginning of each assessment or intervention session for up to 20 sessions, up to 8 weeks

ArmMeasureValue (NUMBER)
TangoNumber of Falls1 Number of falls
Home Exercise (HEX)Number of Falls0 Number of falls
Secondary

Number of Falls

the number of falls or near falls experienced by the participant in the 6 months post-intervention. All reported falls throughout the follow-up time period will be totaled and reported by arm

Time frame: 6 months post-intervention

ArmMeasureValue (NUMBER)
TangoNumber of Falls0 Number of falls
Home Exercise (HEX)Number of Falls1 Number of falls
Secondary

Postural Control (Complexity)

sample entropy of the center of pressure (COP). Sample entropy is a non-linear COP measure that determines the irregularity of a time-series. Sample entropy of the resultant COP position will be calculated using the increment calculation method (SEI) with constant values applied of m = 3 and r = 0.3. Entropy of postural responses represents the automatic complexity of neuromotor control that is available to an individual. Sample entropy scores won't go below 0 or above 2, and higher values indicate better complexity in postural response

Time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention

Population: The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
TangoPostural Control (Complexity)Baseline0.480 sample entropy scoreStandard Deviation 0.157
TangoPostural Control (Complexity)Week 80.558 sample entropy scoreStandard Deviation 0.161
TangoPostural Control (Complexity)Follow-up Visit (4 weeks post-intervention)0.559 sample entropy scoreStandard Deviation 0.121
Home Exercise (HEX)Postural Control (Complexity)Baseline0.467 sample entropy scoreStandard Deviation 0.12
Home Exercise (HEX)Postural Control (Complexity)Week 80.566 sample entropy scoreStandard Deviation 0.124
Home Exercise (HEX)Postural Control (Complexity)Follow-up Visit (4 weeks post-intervention)0.559 sample entropy scoreStandard Deviation 0.103
Secondary

Postural Control (Complexity) at Tango Sessions

sample entropy of the center of pressure (COP). Sample entropy is a non-linear COP measure that determines the irregularity of a time-series. Sample entropy of the resultant COP position will be calculated using the increment calculation method (SEI) with constant values applied of m = 3 and r = 0.3. Entropy of postural responses represents the automatic complexity of neuromotor control that is available to an individual. Sample entropy scores won't go below 0 or above 2, and higher values indicate better complexity in postural responseThe mean will be taken of all beginning of session data points together and all end of session data points together

Time frame: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

Population: Postural control at Tango sessions were only measured for participants in the Tango arm.

ArmMeasureGroupValue (MEAN)Dispersion
TangoPostural Control (Complexity) at Tango SessionsBeginning of Sessions0.520 sample entropy scoreStandard Deviation 0.145
TangoPostural Control (Complexity) at Tango SessionsEnd of Sessions0.546 sample entropy scoreStandard Deviation 0.18
Secondary

Postural Control (Ellipse Area)

95% ellipse area of the COP

Time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention

Population: The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
TangoPostural Control (Ellipse Area)Baseline1023 millimeters squaredStandard Deviation 1052
TangoPostural Control (Ellipse Area)Week 8595 millimeters squaredStandard Deviation 618
TangoPostural Control (Ellipse Area)Follow-up Visit (4 weeks post-intervention)570 millimeters squaredStandard Deviation 606
Home Exercise (HEX)Postural Control (Ellipse Area)Baseline775 millimeters squaredStandard Deviation 441
Home Exercise (HEX)Postural Control (Ellipse Area)Week 8574 millimeters squaredStandard Deviation 389
Home Exercise (HEX)Postural Control (Ellipse Area)Follow-up Visit (4 weeks post-intervention)647 millimeters squaredStandard Deviation 323
Secondary

Postural Control (Ellipse Area) at Tango Sessions

95% ellipse area of the COP. The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.

Time frame: at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

Population: Postural control at Tango sessions were only measured for participants in the Tango arm.

ArmMeasureGroupValue (MEAN)Dispersion
TangoPostural Control (Ellipse Area) at Tango SessionsBeginning of Sessions749 millimeters squaredStandard Deviation 874
TangoPostural Control (Ellipse Area) at Tango SessionsEnd of Sessions748 millimeters squaredStandard Deviation 856
Secondary

Postural Control (Variability) at Tango Sessions

root-mean square of the center of pressure (COP). The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.

Time frame: at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

Population: Postural control at Tango sessions were only measured for participants in the Tango arm.

ArmMeasureGroupValue (MEAN)Dispersion
TangoPostural Control (Variability) at Tango SessionsBeginning of Sessions8.86 millimetersStandard Deviation 4.43
TangoPostural Control (Variability) at Tango SessionsEnd of Sessions8.74 millimetersStandard Deviation 4.48
Secondary

Postural Control (Velocity)

velocity of COP

Time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention

Population: The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
TangoPostural Control (Velocity)Baseline10.2 millimeters per secondStandard Deviation 6.31
TangoPostural Control (Velocity)Week 87.51 millimeters per secondStandard Deviation 3.56
TangoPostural Control (Velocity)Follow-up Visit (4 weeks post-intervention)9.21 millimeters per secondStandard Deviation 5.99
Home Exercise (HEX)Postural Control (Velocity)Baseline12.1 millimeters per secondStandard Deviation 5.86
Home Exercise (HEX)Postural Control (Velocity)Week 87.92 millimeters per secondStandard Deviation 4.12
Home Exercise (HEX)Postural Control (Velocity)Follow-up Visit (4 weeks post-intervention)8.64 millimeters per secondStandard Deviation 2.79
Secondary

Postural Control (Velocity) at Tango Sessions

velocity of COP. The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.

Time frame: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

Population: Postural control at Tango sessions were only measured for participants in the Tango arm.

ArmMeasureGroupValue (MEAN)Dispersion
TangoPostural Control (Velocity) at Tango SessionsBeginning of Sessions8.87 millimeters per secondStandard Deviation 5.33
TangoPostural Control (Velocity) at Tango SessionsEnd of Sessions8.08 millimeters per secondStandard Deviation 4.37
Other Pre-specified

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.

Time frame: 1 month follow-up post-intervention

Other Pre-specified

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

Time frame: 8 weeks

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026