NCT05114005

Tango for Neuropathy Among Breast Cancer Survivors

Completed NA Results posted Last updated 15 September 2025

What this trial tests

NA trial testing Rhythmic Auditory Stimulation in Cancer, Breast in 52 participants. Completed in 15 April 2024.

Timeline

15 August 2021

Primary endpoint
15 April 2024

15 April 2024

Quick facts

Lead sponsor	Ohio State University Comprehensive Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	52
Start date	15 August 2021
Primary completion	15 April 2024
Estimated completion	15 April 2024
Sites	1 location across United States

Drugs / interventions tested

• Rhythmic Auditory Stimulation
• Evidence-Based Exercise

Conditions studied

• Cancer, Breast — all drugs for Cancer, Breast →
• Neuropathy — all drugs for Neuropathy →

Sponsor

Ohio State University Comprehensive Cancer Center

Who can join

40 and older, any sex, with Cancer, Breast or Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Postural Control (Variability) Primary · At baseline, week 8 of intervention, and at 4 week follow-up post intervention

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

Baseline

Group	Value	95% CI
Tango	10.3	± 4.93
Home Exercise (HEX)	9.64	± 2.42

Week 8

Group	Value	95% CI
Tango	8.03	± 3.54
Home Exercise (HEX)	8.00	± 2.82

Follow-up Visit (4 weeks post-intervention)

Group	Value	95% CI
Tango	7.74	± 3.67
Home Exercise (HEX)	8.61	± 2.31

Intrinsic Motivation Primary · Assessed at week 4, week 8, and week 12

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.

4 weeks

Group	Value	95% CI
Tango	6	6 – 11.5
Home Exercise (HEX)	21.5	19 – 24

8 weeks

Group	Value	95% CI
Tango	6	6 – 8.5
Home Exercise (HEX)	18	14.2 – 20

12 weeks

Group	Value	95% CI
Tango	6	6 – 6
Home Exercise (HEX)	16	14 – 19

Postural Control (Ellipse Area) Secondary · At baseline, week 8 of intervention, and at 4 week follow-up post intervention

95% ellipse area of the COP

Baseline

Group	Value	95% CI
Tango (TEX)	1023	± 1052
Home Exercise (HEX)	775	± 441

Week 8

Group	Value	95% CI
Tango (TEX)	595	± 618
Home Exercise (HEX)	574	± 389

Follow-up Visit (4 weeks post-intervention)

Group	Value	95% CI
Tango (TEX)	570	± 606
Home Exercise (HEX)	647	± 323

Postural Control (Velocity) Secondary · At baseline, week 8 of intervention, and at 4 week follow-up post intervention

velocity of COP

Baseline

Group	Value	95% CI
Tango (TEX)	10.2	± 6.31
Home Exercise (HEX)	12.1	± 5.86

Week 8

Group	Value	95% CI
Tango (TEX)	7.51	± 3.56
Home Exercise (HEX)	7.92	± 4.12

Follow-up Visit (4 weeks post-intervention)

Group	Value	95% CI
Tango (TEX)	9.21	± 5.99
Home Exercise (HEX)	8.64	± 2.79

Postural Control (Complexity) Secondary · At baseline, week 8 of intervention, and at 4 week follow-up post intervention

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

Baseline

Group	Value	95% CI
Tango (TEX)	0.480	± 0.157
Home Exercise (HEX)	0.467	± 0.120

Week 8

Group	Value	95% CI
Tango (TEX)	0.558	± 0.161
Home Exercise (HEX)	0.566	± 0.124

Follow-up Visit (4 weeks post-intervention)

Group	Value	95% CI
Tango (TEX)	0.559	± 0.121
Home Exercise (HEX)	0.559	± 0.103

Postural Control (Variability) at Tango Sessions Secondary · at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

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.

Beginning of Sessions

Group	Value	95% CI
Tango (TEX)	8.86	± 4.43

End of Sessions

Group	Value	95% CI
Tango (TEX)	8.74	± 4.48

Postural Control (Ellipse Area) at Tango Sessions Secondary · at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

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.

Beginning of Sessions

Group	Value	95% CI
Tango (TEX)	749	± 874

End of Sessions

Group	Value	95% CI
Tango (TEX)	748	± 856

Postural Control (Velocity) at Tango Sessions Secondary · at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

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.

Beginning of Sessions

Group	Value	95% CI
Tango (TEX)	8.87	± 5.33

End of Sessions

Group	Value	95% CI
Tango (TEX)	8.08	± 4.37

Postural Control (Complexity) at Tango Sessions Secondary · at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

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 po

Beginning of Sessions

Group	Value	95% CI
Tango (TEX)	0.520	± 0.145

End of Sessions

Group	Value	95% CI
Tango (TEX)	0.546	± 0.180

Clinical Measure of Balance Function Secondary · At baseline, week 4 of intervention, and at 4 week follow-up post intervention, up to 12 weeks

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.

Baseline

Group	Value	95% CI
Tango (TEX)	10.3	± 2.47
Home Exercise (HEX)	11.7	± 5.21

Week 4

Group	Value	95% CI
Tango (TEX)	8.65	± 1.92
Home Exercise (HEX)	8.25	± 1.74

Follow-up Visit (4 weeks post-intervention)

Group	Value	95% CI
Tango (TEX)	8.49	± 1.79
Home Exercise (HEX)	7.70	± 1.25

Neuropathy Symptoms Score at Tango Sessions Secondary · at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks

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

Beginning of sessions

Group	Value	95% CI
Tango (TEX)	6.68	± 4.25

End of sessions

Group	Value	95% CI
Tango (TEX)	3.29	± 3.01

Neuropathy Symptoms Score Secondary · At week 8 of intervention and at 4-week follow-up post intervention

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.

Week 8

Group	Value	95% CI
Tango (TEX)	6.60	± 3.97
Home Exercise (HEX)	6.89	± 7.41

Follow-up (4 weeks post-intervention)

Group	Value	95% CI
Tango (TEX)	7.06	± 4.08
Home Exercise (HEX)	5.18	± 5.36

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 24 weeks. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tango (TEX)

Serious: 1/26 (4%)

Deaths: 0/26

Home Exercise (HEX)

Serious: 2/26 (8%)

Deaths: 0/26

Serious adverse events (3 terms)

Reaction	System	Tango (TEX)	Home Exercise (HEX)
Hospitalized due to low hemoglobin	Blood and lymphatic system disorders	—	—
Hospitalized due to fall	Injury, poisoning and procedural complications	—	—
Hospitalized due to fall with broken wrist	Injury, poisoning and procedural complications	—	—

Other adverse events (38 terms — click to expand)

Reaction	System	Tango (TEX)	Home Exercise (HEX)
Feeling unwell/ cold	General disorders	—	—
Fall/LOB- uninjured	Injury, poisoning and procedural complications	—	—
COVID+	Infections and infestations	—	—
Knee pain	Musculoskeletal and connective tissue disorders	—	—
Migraine	Nervous system disorders	—	—
Ankle pain (possibly tendonitis per Dr)	Musculoskeletal and connective tissue disorders	—	—
Cancer recurrence	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
GI distress	Gastrointestinal disorders	—	—
Head cold sinuses	Infections and infestations	—	—
Hip pain	Musculoskeletal and connective tissue disorders	—	—
Infection Axilla	Skin and subcutaneous tissue disorders	—	—
Infection Sinus/Ear	Infections and infestations	—	—
Planned surgery: chemo port removed	Surgical and medical procedures	—	—
Planned surgery: melanoma removed	Surgical and medical procedures	—	—
Plantar fasciitis	Musculoskeletal and connective tissue disorders	—	—
Poison ivy	Skin and subcutaneous tissue disorders	—	—
Shoulder pain during tango INT	Musculoskeletal and connective tissue disorders	—	—
Sinus infection	Infections and infestations	—	—
Stress fracture hip	Musculoskeletal and connective tissue disorders	—	—
Thumb strain	Musculoskeletal and connective tissue disorders	—	—
Tripped; would have fallen if son-in-law hadn't caught	Injury, poisoning and procedural complications	—	—
Vaccine reaction	Skin and subcutaneous tissue disorders	—	—
Walking pneumonia	Infections and infestations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Broken toe	Musculoskeletal and connective tissue disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Endoscopy	Surgical and medical procedures	—	—
Kidney infection	Infections and infestations	—	—
Knee arthritis pain	Musculoskeletal and connective tissue disorders	—	—
Left hip discomfort	Musculoskeletal and connective tissue disorders	—	—
Long COVID headache	Nervous system disorders	—	—
Nerve pain	Nervous system disorders	—	—
Pneumonia	Infections and infestations	—	—
Sinus infection and symptoms of POTS	Infections and infestations	—	—
Steroid injection for foot pain	Musculoskeletal and connective tissue disorders	—	—
Symptoms of Postural Orthostatic Tachycardia Syndrome (POTS)	Cardiac disorders	—	—
Trauma to toe	Musculoskeletal and connective tissue disorders	—	—
Trigger finger	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Hospitalized due to low hemoglobin, Hospitalized due to fall, Hospitalized due to fall with broken wrist.

Data from ClinicalTrials.gov NCT05114005 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trial and preliminary baseline data.
   Lantis K, Schnell P, Bland CR, Wilder J, et al · · 2023 · cited 7× · PMID 37658464 · DOI 10.1186/s13063-023-07554-z
2. Partnered dance evokes greater intrinsic motivation than home exercise as therapeutic activity for chemotherapy-induced deficits: secondary results of a randomized, controlled clinical trial.
   Worthen-Chaudhari L, Schnell PM, Hackney ME, Lustberg MB. · · 2024 · cited 4× · PMID 38962217 · DOI 10.3389/fpsyg.2024.1383143
3. Neurologic dance training and home exercise improve motor-cognitive dual-task function similarly, but through potentially different mechanisms, among breast cancer survivors with chemotherapy-induced neuropathy: Initial results of a randomized, controlled clinical trial.
   Worthen-Chaudhari LC, Crasta JE, Schnell PM, Lantis K, et al · · 2025 · cited 3× · PMID 39584292 · DOI 10.1177/13872877241291440
4. Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trail and preliminary baseline data
   Lantis KD, Schnell P, Bland CR, Wilder J, et al · · 2023 · DOI 10.21203/rs.3.rs-2988661/v1