This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Tango for Neuropathy Among Breast Cancer Survivors (NCT05114005), a randomized na study. The primary outcome is Postural Control (Variability).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05114005 |
| Phase | NA |
| Condition | Cancer, Breast, Neuropathy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 52 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
| Results posted | Yes |
2. Clinical Question
The study asks whether a dance-based program and a structured home exercise program are associated with different patterns of postural control among breast cancer survivors with neuropathy. The primary measure is postural-control variability, described as the root mean square of the center of pressure. It is recorded at baseline, at week 8 of the intervention, and at a 4 week follow-up after the intervention.
The intervention is Argentine Tango taught in partnered sessions. The comparator is a structured home exercise program. The registry describes both as behavioral interventions. The primary outcome is continuous and is summarized as a mean with a standard deviation. Secondary outcomes include other postural-control measures and a clinical measure of balance function.
Population
Breast cancer survivors with neuropathy are the population of interest. The registry identifies breast cancer and neuropathy as the conditions. The number analyzed at each outcome time point is defined as the number who participated in the postural-control tests at that time point; the actual time-specific numbers are not reported in the registry record.
Intervention
The Tango program consists of 16 Argentine Tango sessions adapted for neurorehabilitation. The sessions are scheduled over 8 weeks, 2x per week, and last 1 hour each.
Comparator
The comparison group receives a structured home exercise program, identified as HEX. The registry describes it as evidence-based and based on an 8 week intervention. Further details about its content are not fully reported in the registry record.
Primary question
How does mean postural-control variability change across baseline, week 8, and the 4 week follow-up in the Tango and home-exercise groups? Numerical primary-outcome results and a reported between-group estimate are not reported in the registry record.
This is a comparative research question, not a basis for an individual treatment decision. The registry record establishes the planned comparison and outcome definitions, but without posted numerical results it does not establish the size, precision, or direction of any group difference.
3. Trial Design
The registry identifies this as a randomized, parallel-group study with no masking. The study is listed as completed. Enrollment is 52. The phase is listed as NA. The sponsor is Ohio State University Comprehensive Cancer Center. The recorded start date is 2021-08-15, and the primary completion date is 2024-04-15.
The two behavioral interventions are Argentine Tango and Home Exercise (HEX). The Tango intervention is described as 16 sessions over 8 weeks, with 2x weekly sessions lasting 1 hour. Its stated purpose is to teach the basic steps of partnered Tango, with adaptations for neurorehabilitation. HEX is described as a structured home program based on an 8 week intervention and recommended by physical therapists specializing in breast cancer within the sponsoring organization. The full exercise content is not reported in the registry record.
Randomization is relevant because, when implemented as intended, it can help balance measured and unmeasured participant characteristics across groups. However, the registry record does not report the randomization procedure, concealment method, or any stratification factors. These details should not be inferred from the label randomized. Masking is listed as none; the record does not describe whether outcome assessors were masked.
The primary outcome is postural-control variability, measured at baseline, at week 8 of intervention, and at a 4 week follow-up post intervention. Its measurement is the root mean square of the center of pressure, in millimeters, and its statistical parameter is the mean with standard deviation. Secondary outcomes include postural-control ellipse area, velocity, complexity, measures taken at Tango sessions, and a clinical measure of balance function. The registry lists 23 outcome measures, but does not report numerical primary-outcome findings or analyses for these outcomes.
The registry record does not report a sample-size justification or the detailed statistical analysis plan. It also does not state how allocation was generated, how missing outcome measurements were handled, or whether any protocol changes occurred. The study's completed status therefore should not be mistaken for evidence that the outcome results are available in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Tango | Home Exercise (HEX) |
|---|---|---|
| STARTED | 26 | 26 |
| Attended Introductory Session | 23 | 22 |
| Adhered Through 4 Weeks of Intervention | 20 | 13 |
| Adhered Through 8 Weeks of Intervention | 17 | 10 |
| Returned for 1 Month Follow-up Post Intervention | 17 | 8 |
| COMPLETED | 17 | 8 |
| NOT COMPLETED | 9 | 18 |
Analysis population for the primary outcome, as defined in the registry: The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Tango | Home Exercise (HEX) | Total |
|---|---|---|---|---|
| Participants analysed | 26 | 26 | 52 | |
| Age, Continuous | years | 63.6 (SD 8.37) | 58.9 (SD 10.4) | 61.2 (SD 9.65) |
| Sex: Female, Male: Female | Participants | 25 | 26 | 51 |
| Sex: Female, Male: Male | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 26 | 26 | 52 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): White | Participants | 23 | 25 | 48 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 26 | 26 | 52 |
6. Primary Endpoint
The registry lists the primary outcome as Postural Control (Variability), measured over At baseline, week 8 of intervention, and at 4 week follow-up post intervention.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | millimeters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is postural-control variability. The registry defines it as the root mean square of the center of pressure (COP), measured in millimeters. The COP is a measure used to characterize how a person maintains balance while standing; variability describes the amount of fluctuation represented by the specified measure. The endpoint is recorded at baseline, at week 8 of intervention, and at a 4 week follow-up post intervention.
The registry specifies a mean as the summary parameter and standard deviation as the measure of dispersion. A mean describes the central value for a group, while a standard deviation describes how spread out individual measurements are around that group mean. These are descriptive summaries; by themselves, they do not establish whether groups differ or whether an observed difference is precise.
Postural-control measures are relevant to this trial because the study concerns neuropathy and balance-related outcomes in breast cancer survivors. The record also lists secondary measures of postural control and a clinical measure of balance function. Those secondary outcomes do not replace the stated primary endpoint, and their presence does not tell whether the primary outcome changed.
The registry record does not report the primary endpoint's group means, standard deviations, changes over time, or a between-group estimate. It also does not provide numerical results at any of the three specified measurement times. Consequently, the direction and magnitude of the primary outcome cannot be described from the registry record. The number analyzed at each time point is defined by participation in postural-control testing, but the actual time-specific numbers are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its measurement schedule, but does not report numerical values for postural-control variability. There are no posted group means, standard deviations, changes from baseline, between-group comparisons, confidence intervals, or primary-outcome p-values in the record. Therefore, it is not possible to determine from the registry record whether the Tango group or the home-exercise group had a higher or lower mean, or how large or precise any difference may have been.
This distinction matters because the design and the outcome definition do not substitute for results. A randomized comparison can support an estimate of a group contrast when outcome data and an analysis are reported. Without those estimates, neither the direction nor the scale of a contrast is available. The completed status and the enrollment figure do not disclose what happened to the outcome measurements.
The registry lists 23 outcome measures and gives secondary outcome names, including postural-control ellipse area, velocity, complexity, variability at Tango sessions, and a clinical measure of balance function. It reports zero analyses. That entry does not provide results for the primary endpoint or the secondary endpoints, and no interpretation of numerical treatment contrasts can be made from it. The record does not report whether outcomes were analyzed but not entered, whether analyses were not conducted, or whether results are available elsewhere.
The adverse-event information is separate from the postural-control outcomes. The registry lists serious adverse events affecting 1 participant in the Tango group and 2 in the HEX group, with zero deaths in each group. It also lists other adverse events affecting 19 participants in the Tango group and 11 in the HEX group. These are descriptive safety counts in the registry record; they do not establish that an event was caused by an intervention. The record does not provide a comparative statistical analysis of adverse events.
Any planning illustration based on a fraction of an observed effect should be understood as a hypothetical sample-size calculation, not as a trial finding or a measure of observed power. No numerical planning estimates are reported in the registry record. The stated assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation. The record does not report a sample-size justification for the completed study.
Overall, the registry supports a description of the question, design, measurement schedule, and reported event counts. It does not support a conclusion about the magnitude, precision, or statistical significance of the primary outcome comparison. The appropriate reading is that the outcome results are not reported in the registry record, rather than that the groups had no difference.
9. Statistical Methods Explained
The registry describes a randomized parallel-group comparison of Argentine Tango and a structured home exercise program. The primary outcome is continuous: postural-control variability in millimeters, summarized by a mean and standard deviation. The time points are baseline, week 8 of intervention, and a 4 week follow-up post intervention. These features identify the outcome and design, but the statistical analysis methods used for the primary comparison are not reported in the registry record.
What does a mean represent?
As a general statistical explanation, a mean is the arithmetic average of the observed values in a group. It gives a compact description of the group's central outcome level, but it does not show how individual values are distributed. A standard deviation describes spread around the mean. Two groups can have similar means but different variability, or different means with considerable overlap in their individual measurements. The registry's stated use of mean and standard deviation does not itself provide either summary value for this trial.
Why does the repeated measurement schedule matter?
As a general explanation, measurements at baseline and later visits can be analyzed in several ways. An analysis might compare follow-up values between randomized groups while accounting for baseline, compare changes from baseline, or model repeated measurements together. Those approaches answer related but not identical questions and can rely on different assumptions. The registry record names the time points but does not report which approach was used, whether a group-by-time comparison was planned, or how correlations among repeated measures were handled. No particular method should be inferred.
The number analyzed at each time point is defined in the record as the number of participants who participated in postural-control testing at that time. The actual numbers at the measurement times are not reported in the registry record. This matters because a participant may have a measurement at one visit but not another. The record does not state how incomplete follow-up was handled, whether an analysis included all randomized participants, or whether inclusion required a completed postural-control test.
How should a confidence interval be understood?
As a general explanation, a confidence interval expresses uncertainty around an estimated quantity, such as a difference in group means. A narrower interval indicates greater precision under the model used; a wider interval indicates less precision. Its interpretation depends on the analysis and assumptions. No confidence interval for the primary outcome is reported in the registry record, so the precision of a treatment contrast cannot be assessed.
What can a p-value say?
As a general explanation, a p-value measures how compatible the observed data are with a specified null model, under the assumptions of the analysis. It does not quantify the size or clinical importance of a difference, and it is not the probability that the null hypothesis is true. The registry record does not report a primary-outcome p-value or a detailed statistical plan, so there is no reported significance test to interpret.
What do the planning assumptions mean?
The registry describes planning illustrations as calculations based on a stated fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. Such calculations are hypothetical illustrations of sample sizes under their assumptions; they are not observed power and do not describe the results of this trial. The record does not report the numerical planning estimates or the observed effect used to form them. It also does not report the trial's own sample-size justification.
As a general explanation, sample-size calculations depend on the effect size one wishes to detect, the variability of the outcome, the significance threshold, and the desired power, along with assumptions about the analysis and allocation. Changing the assumed effect changes the illustrative sample size. A calculation based on an effect observed in a study is especially not evidence that the study had a specified probability of detecting that effect before data were collected. It is a planning illustration, not observed power.
How do the event counts differ from an outcome analysis?
The adverse-event entries are counts of participants with events in each group, whereas the primary endpoint is a continuous measurement. The registry lists counts for serious and other adverse events and deaths, but it does not report a statistical comparison of those counts. As a general explanation, a descriptive count does not by itself establish a causal relationship or quantify uncertainty in a group contrast. The registry's event descriptions should therefore be read as reported safety information, not as an adjusted treatment-effect analysis.
The record lists 23 outcome measures and zero analyses. It does not report whether the primary endpoint was examined using a prespecified model, whether any covariates were included, or how secondary endpoints were handled. These absences limit statistical interpretation: a reader cannot reconstruct the analysis, judge its assumptions, or evaluate reported precision because those results and methods are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 23 outcome measures, including the primary postural-control variability measure and multiple secondary postural-control outcomes. It reports zero analyses. The registry record does not report a multiplicity procedure, such as a prespecified hierarchy, adjustment across tests, or another approach to interpreting several outcomes. It also does not report whether a particular outcome was designated as the sole confirmatory comparison beyond identifying postural-control variability as primary.
As a general statistical point, examining many outcomes or time points can increase the chance of obtaining an apparently notable result by chance if each test is treated as independent evidence. Multiplicity procedures can help control that risk, but they may also change how estimates and tests are interpreted. No adjustment method or testing hierarchy should be inferred for this study because one is not reported in the registry record.
The registry defines the number analyzed at each time point as the number who participated in postural-control tests at that time. It does not report the actual analyzed numbers at baseline, week 8, or follow-up, or the reasons any measurements might be absent. The missing-data method is not reported in the registry record. There is also no report of imputation, complete-case analysis, or sensitivity analysis.
The analysis population is not specified. The record does not state whether results were analyzed according to randomized group, restricted to participants who completed the intervention, or based on another population. These distinctions can affect interpretation if outcomes or participation differ between groups. Without reported results, analysis methods, and time-specific participant counts, the extent and handling of missing data and the impact of multiple outcomes cannot be evaluated.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Tango (TEX) | 1 | 26 | 3.8% |
| Home Exercise (HEX) | 2 | 26 | 7.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Tango (TEX) | 0 of 26 |
| Home Exercise (HEX) | 0 of 26 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Tango (TEX) | 19 of 26 |
| Home Exercise (HEX) | 11 of 26 |
Most frequent serious adverse event terms
| Event term | Organ system | Tango (TEX) | Home Exercise (HEX) |
|---|---|---|---|
| Hospitalized due to low hemoglobin | Blood and lymphatic system disorders | 1 of 26 | 0 of 26 |
| Hospitalized due to fall | Injury, poisoning and procedural complications | 0 of 26 | 1 of 26 |
| Hospitalized due to fall with broken wrist | Injury, poisoning and procedural complications | 0 of 26 | 1 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Tango (TEX) | Home Exercise (HEX) |
|---|---|---|---|
| Feeling unwell/ cold | General disorders | 4 of 26 | 7 of 26 |
| Fall/LOB- uninjured | Injury, poisoning and procedural complications | 6 of 26 | 2 of 26 |
| COVID+ | Infections and infestations | 3 of 26 | 2 of 26 |
| Knee pain | Musculoskeletal and connective tissue disorders | 3 of 26 | 0 of 26 |
| Migraine | Nervous system disorders | 1 of 26 | 2 of 26 |
| GI distress | Gastrointestinal disorders | 1 of 26 | 1 of 26 |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | 1 of 26 | 1 of 26 |
| Sinus infection | Infections and infestations | 1 of 26 | 1 of 26 |
| Ankle pain (possibly tendonitis per Dr) | Musculoskeletal and connective tissue disorders | 1 of 26 | 0 of 26 |
| Cancer recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 26 | 0 of 26 |
Serious events with the highest arm-level rate: hospitalized due to low hemoglobin (3.8%), hospitalized due to fall (3.8%), hospitalized due to fall with broken wrist (3.8%).
The registry reports serious adverse events for each group: 1 participant in the Tango group and 2 participants in the Home Exercise (HEX) group. It reports other adverse events for 19 participants in the Tango group and 11 participants in the HEX group. Deaths are listed as zero in each group. These figures are registry-record counts, not a reported statistical comparison.
The record lists the following serious-event terms with their reported percentages: Hospitalized due to low hemoglobin, 3.8%; Hospitalized due to fall, 3.8%; and Hospitalized due to fall with broken wrist, 3.8%. These entries describe events recorded in the registry. The record does not establish whether an event was caused by Tango, HEX, or another factor, and it does not provide an adjusted comparison of event risk.
As a general statistical explanation, adverse-event counts are best interpreted alongside the definitions used to collect them, the period of observation, and the completeness of reporting. Those details are not fully reported in the registry record. The serious and other event counts should not be combined or interpreted as a treatment effect, and the listed percentages should be read as the registry reports them. The counts alone do not establish whether the groups differ in safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was a randomized, parallel-group comparison of Tango with a structured home exercise program, and that the primary endpoint was postural-control variability measured at baseline, week 8, and a 4 week follow-up. It also identifies the outcome's unit and summary parameter. These details make the research question and measurement schedule clear.
However, the record does not report numerical primary-outcome results. There are no reported group means, standard deviations, changes over time, between-group estimates, confidence intervals, or primary-outcome tests. As a result, the posted information does not show whether the groups differed, in which direction a difference might lie, or how precisely it could be estimated. Missing results are not evidence of no effect or of equivalence.
The study's completed status and enrollment of 52 do not supply the missing outcome estimates. Nor do the adverse-event counts answer the primary postural-control question. The registry lists serious and other adverse events and deaths by group, but does not report a causal assessment or comparative analysis. Those counts should be treated as descriptive entries.
The record also does not report the detailed statistical plan, analysis population, handling of missing measurements, or multiplicity strategy. Such information is important for understanding how repeated measurements and several outcomes were analyzed. Without it, readers cannot assess whether the analysis followed a prespecified approach or evaluate the assumptions behind a treatment contrast.
Accordingly, the registry record can be used to describe the trial design, intervention schedules, outcome definitions, and reported safety counts. It cannot be used to estimate the direction, size, precision, or statistical significance of the primary comparison. Any broader claim about the comparative impact of Tango and home exercise would go beyond the results reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it evaluates a behavioral intervention against an active exercise comparator rather than an untreated group. A randomized comparison can, in principle, estimate a contrast between these two programs in the study population. The parallel design and repeated measurement schedule also raise practical questions about baseline adjustment, follow-up, and how changes over time should be analyzed.
The primary endpoint is a continuous measure of postural control, reported in millimeters and defined as the root mean square of the center of pressure. Continuous measurements can convey more gradation than a simple event count, but their interpretation depends on the measurement definition, variability, analysis model, and a meaningful comparison. The registry gives the endpoint definition and time points, but not outcome values or a between-group estimate.
The study also lists several secondary outcomes. When a study assesses many measures, readers need to know which comparisons were prioritized and how multiplicity was addressed. The registry lists 23 outcome measures and zero analyses, but does not report a multiplicity strategy or results. This makes it impossible to evaluate the consistency of findings across endpoints or distinguish a primary finding from exploratory comparisons.
Finally, this record illustrates the difference between a trial being completed and its results being interpretable from a registry entry. Design information and adverse-event counts are useful, but they do not replace estimates of outcome differences with uncertainty measures. The absence of reported primary results is a central statistical limitation, not evidence that the groups had identical outcomes.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A major limitation for interpreting this specific trial is that the registry record does not report numerical results for its primary endpoint. It identifies the measure, unit, summary parameter, and assessment times, but provides no means, standard deviations, changes, between-group contrasts, confidence intervals, or p-values. The direction, magnitude, and precision of any primary-outcome difference therefore cannot be assessed.
The record also lists 23 outcome measures and zero analyses, without reporting how secondary outcomes were analyzed or how multiplicity was handled. The statistical analysis plan is not reported in the registry record. There is no reported method for analyzing repeated measures, adjusting for baseline, selecting covariates, or defining the analysis population.
Although the registry explains that the analyzed number at each time point represents participants who took part in postural-control testing, the actual time-specific numbers are not reported. Reasons for missing measurements and their handling are also not reported. This prevents assessment of follow-up completeness and whether missing measurements could affect comparisons.
The study is listed as randomized and unmasked, but the randomization method, allocation concealment, and masking of outcome assessors are not reported in the registry record. The full content of the home exercise program is also not reported. These omissions limit assessment of implementation and potential measurement or performance differences between groups.
The registry's serious and other adverse-event counts are descriptive and lack a reported comparative analysis or causal assessment. The record does not report a sample-size justification, and its planning assumptions do not provide numerical estimates. These limitations mean the available registry information is useful for describing the study but insufficient for a full evaluation of its primary outcome or statistical robustness.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Tango for Neuropathy Among Breast Cancer Survivors — NCT05114005.
- Registry record last updated 2025-09-15; status last verified 2025-08.
- Results first posted 2025-09-15.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed randomized, parallel-group study of Argentine Tango versus a structured Home Exercise program among breast cancer survivors with neuropathy. Masking is listed as none, enrollment is 52, and the phase is listed as NA. The sponsor is Ohio State University Comprehensive Cancer Center.
The primary endpoint is postural-control variability, defined as the root mean square of the center of pressure and measured in millimeters. It is assessed at baseline, week 8 of intervention, and a 4 week follow-up post intervention, with a mean and standard deviation specified as the summary. The registry lists 23 outcome measures and zero analyses.
Serious adverse events are reported for 1 participant in the Tango group and 2 in the HEX group; other adverse events are reported for 19 and 11 participants, respectively. Deaths are listed as zero in each group. Numerical primary-outcome results, the detailed statistical plan, and missing-data methods are not reported in the registry record.