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 The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients (NCT01996410), a randomized na study. The primary outcome is MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01996410 |
| Phase | NA |
| Condition | Breast Cancer Stages I Through III |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | OhioHealth |
| Results posted | Yes |
2. Clinical Question
Population
Patients with breast cancer stages I through III who were receiving chemotherapy. The registry describes four chemotherapy regimens, including regimens in adjuvant and neoadjuvant settings. The record reports enrollment of 10 patients, but does not report how many completed treatment or contributed data to any symptom analysis.
Intervention
Acupuncture during chemotherapy. The registry lists acupuncture as the intervention and describes acupuncture as the experimental group assignment. Details of acupuncture delivery are incomplete in the arm descriptions, so the full schedule and procedure are not reported in the registry record.
Comparator
No acupuncture during chemotherapy. The comparison was intended to assess symptom scores between patients assigned to acupuncture and those assigned to control. The trial was randomized and used a parallel-group design, with no masking reported.
Primary question
Would MD Anderson Symptom Inventory scores for chemotherapy-associated symptoms be lower over the course of chemotherapy in the acupuncture group than in the control group? The planned outcome covered 13 separate MDASI items, which the registry says are not summative. No analyzed group comparison or symptom result is reported.
3. Trial Design
This was a randomized, parallel-group trial with no masking reported. It enrolled patients with breast cancer stages I through III receiving chemotherapy and compared acupuncture with no acupuncture. The registry lists four chemotherapy regimens, with separate acupuncture and no-acupuncture groups for each regimen. Some regimen descriptions identify adjuvant or neoadjuvant treatment settings, but the arm descriptions are truncated and do not fully specify the acupuncture procedures.
The registry reports enrollment of 10. It identifies OhioHealth as the sponsor and gives a start date of 2013-11 and a primary completion date of 2015-01. The study status is terminated. The reason for termination is not reported in the registry record.
The primary outcome was MDASI scores for chemotherapy-associated symptoms, with a timeframe of 15 months. The registry describes a planned comparison of symptom scores over time between acupuncture and control groups. It also states that the investigators were not permitted to analyze the 10 enrolled patients because completed enrollment numbers were not met. The required enrollment target, the number of patients who completed the study, and the number with symptom data are not reported in the registry record.
The registry lists the study phase as NA. It does not report a completed primary outcome analysis, estimates of group differences, confidence intervals, or p-values. The record also does not report an analysis population such as intention-to-treat or per-protocol.
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.
Only the first 6 of 8 groups are shown.
Overall Study
| Stage | Chemotherapy 1 Acupuncture | Chemotherapy 2 Acupuncture | Chemotherapy 3 Acupuncture | Chemotherapy 4 Acupuncture | Chemotherapy 1 No Acupuncture | Chemotherapy 2 No Acupuncture |
|---|---|---|---|---|---|---|
| STARTED | 3 | 3 | 0 | 0 | 2 | 2 |
| COMPLETED | 3 | 3 | 0 | 0 | 2 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Per IRB guidelines, we were not permitted to analyze the 10 patients enrolled since we did not meet completed enrollment numbers.
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.
Only the first 6 of 9 groups are shown.
| Characteristic | Unit | Chemotherapy 1 Acupuncture | Chemotherapy 2 Acupuncture | Chemotherapy 3 Acupuncture | Chemotherapy 4 Acupuncture | Chemotherapy 1 No Acupuncture | Chemotherapy 2 No Acupuncture |
|---|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 0 | 0 | 2 | 2 | |
| Age, Categorical: <=18 years | participants | 0 | 0 | — | — | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | participants | 1 | 3 | — | — | 2 | 2 |
| Age, Categorical: >=65 years | participants | 2 | 0 | — | — | 0 | 0 |
| Age, Continuous | years | 56.9 (SD 15.7) | 43.2 (SD 12.0) | — | — | 45.0 (SD 14.9) | 49.0 (SD 18.1) |
| Gender: Female | participants | 3 | 3 | — | — | 2 | 2 |
| Gender: Male | participants | 0 | 0 | — | — | 0 | 0 |
| Region of Enrollment: United States | participants | 3 | 3 | — | — | 2 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment, measured over 15 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerned chemotherapy-associated symptoms measured with the M.D. Anderson Symptom Inventory (MDASI). The registry names nausea, vomiting, fatigue, anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and peripheral neuropathy in its study summary. It describes the primary outcome as MDASI scores and says the instrument consists of 13 separate core items that are not summed into a single total.
For this trial, the planned question was whether MDASI scores over the course of chemotherapy differed between the acupuncture and control groups. The registry's stated hypothesis was that scores would be lower over time in the acupuncture group. Patient-reported symptom measures are used to record the experience and severity of symptoms from the patient's perspective; this is a general explanation of the purpose of such measures, not a finding from this trial.
The registry gives a timeframe of 15 months and describes plotting the scores over time, followed by a planned comparison using linear mixed models. However, it reports that the enrolled patients were not analyzed because completed enrollment numbers were not met. No scores, changes, or between-group estimates are reported, so the endpoint does not yield a posted result about symptom differences.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record contains no analyzed primary outcome result. Although it describes a plan to compare MDASI scores over time between acupuncture and control groups, it states that analysis of the 10 enrolled patients was not permitted because completed enrollment numbers were not met. Accordingly, there are no reported score trajectories, group differences, confidence intervals, or p-values to interpret.
This absence of an analyzed result does not establish that the groups had the same symptoms, and it does not establish that they differed. It means the registry does not report an estimate of the treatment contrast for the primary outcome. The hypothesis in the study summary—that MDASI scores would be lower over chemotherapy in the acupuncture group—is a stated expectation, not an observed result.
Several features further constrain interpretation. The study was randomized, but masking was listed as none. The enrolled population was limited to 10, and the registry explicitly says enrollment requirements were not met for analysis. The record does not report how many patients completed treatment, how many had symptom measurements at each time point, or whether any patients withdrew. It also does not report details of the target enrollment or the reason the study was terminated.
The registry lists safety counts separately by chemotherapy regimen and assignment. For the regimen 1 acupuncture group, 3 were at risk and 0 were affected for serious adverse events; the corresponding no-acupuncture group lists 2 at risk and 0 affected. For regimen 2, the acupuncture group lists 3 at risk and 0 affected, while the no-acupuncture group lists 2 at risk and 0 affected. Regimens 3 and 4 list 0 at risk and 0 affected in both assignment groups. Death counts are null, not zero. These entries should be read as the recorded safety data, not as a comprehensive demonstration of safety.
Overall, the record documents a planned randomized comparison but does not provide an analyzed symptom outcome. It therefore cannot quantify the direction, size, or precision of any difference between the groups.
9. Statistical Methods Explained
The registry describes a plan to inspect MDASI scores over time and then compare acupuncture and control groups using linear mixed models. These are planned methods; the record says the enrolled patients were not analyzed because completed enrollment numbers were not met. The statistical concepts below explain the stated approach generally and do not imply that these analyses were completed.
Why use a linear mixed model?
Repeated symptom measurements from the same patient are related: a patient's score at one time may be more similar to that patient's other scores than to scores from another patient. A linear mixed model can represent that within-patient dependence while estimating differences associated with group and time. This is a general description of the method. The particular model terms, covariance structure, estimation method, and diagnostic checks are not reported in the registry record.
The registry specifically says the model would account for multiple measurements within a patient. It also states that the investigators could specify how time points are correlated within patients rather than assuming equal correlation across time points. Different correlation patterns can matter because repeated observations may be more or less related depending on their timing. The record does not identify which correlation structure would have been selected or whether model selection was planned.
How does this differ from repeated-measures ANOVA?
The registry says a mixed model was preferred to repeated-measures ANOVA because it allows missing time points within a patient without automatically eliminating that patient from the analysis. In general, a repeated-measures analysis may require a complete set of measurements for the modeled occasions, whereas mixed-model approaches can use available observations under their modeling assumptions. This does not mean that missing data cease to be a concern. Inference can depend on why measurements are missing and on whether the model assumptions are reasonable.
The record does not describe the extent or pattern of missing symptom measurements, the assumptions about missingness, or any sensitivity analysis. It also does not report whether the mixed-model plan included baseline adjustment, treatment-by-time terms, random effects, or other covariates. Those details cannot be inferred from the general description of the method.
What does the planned visual inspection contribute?
The investigators planned to plot MDASI scores over time for the acupuncture and control groups to inspect for differences. As a general statistical practice, plots can reveal broad patterns, variability, and irregularities that a single summary may conceal. They do not by themselves establish a statistically reliable treatment difference, and visual impressions can be affected by sparse data or incomplete follow-up. The registry does not report that these plots were produced or describe any observed pattern.
Why was multiplicity considered?
The registry states that the MDASI contains 13 separate items and that the items are not summative. Testing each symptom separately can create a multiplicity problem: when many statistical tests are conducted, the chance of at least one apparently significant result can increase. As a general approach, adjusting the significance threshold can limit that concern. The stated threshold was 0.003, described as 0.05/13. No item-specific p-values or completed tests are reported, so there is no observed finding to assess against that threshold.
What can be concluded from the methods description?
The record describes an intended longitudinal comparison and a way to account for within-patient measurements, along with a stated adjustment for testing multiple MDASI items. These are features of the planned analysis, not evidence that the method was applied. The registry reports 0 analyses and says the patients were not permitted to be analyzed under the enrollment requirements. The specific statistical model, its estimates, uncertainty, diagnostics, and any deviations from the plan are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies 13 separate MDASI items and says they are not summative. It states that the significance level for all statistical tests would be 0.003 (0.05/13) to account for multiple comparisons. This is the stated plan for controlling the interpretation of tests across symptom items. The record does not report completed tests, item-specific results, or whether this threshold was applied in an analysis.
The investigators planned to use linear mixed models, which they described as allowing missing time points within a patient without removing that patient automatically. In general, this can make use of available repeated measurements, but it does not guarantee that missing data have no effect on the findings. The reasons measurements may be absent and the assumptions used to address missingness matter. The registry does not report missing-data patterns, missingness assumptions, imputation, or sensitivity analyses.
The registry says analysis of the 10 enrolled patients was not permitted because completed enrollment numbers were not met. It does not identify an analyzed population, report how many patients completed treatment, or state how patients with incomplete measurements would have been handled. Intention-to-treat, per-protocol, and other analysis populations are not reported in the registry record. As a result, neither the handling of missing symptom data nor the population for a primary analysis can be evaluated from the posted record.
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 |
|---|---|---|---|
| Chemotherapy 1 Acupuncture | 0 | 3 | 0.0% |
| Chemotherapy 1 No Acupuncture | 0 | 2 | 0.0% |
| Chemotherapy 2 Acupuncture | 0 | 3 | 0.0% |
| Chemotherapy 2 No Acupuncture | 0 | 2 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Chemotherapy 1 Acupuncture | 0 of 3 |
| Chemotherapy 1 No Acupuncture | 0 of 2 |
| Chemotherapy 2 Acupuncture | 0 of 3 |
| Chemotherapy 2 No Acupuncture | 0 of 2 |
| Chemotherapy 3 Acupuncture | 0 of 0 |
| Chemotherapy 3 No Acupuncture | 0 of 0 |
The registry reports serious and other adverse-event counts by chemotherapy regimen and assignment group. For regimen 1, the acupuncture group lists 3 at risk and 0 affected for serious events, and the no-acupuncture group lists 2 at risk and 0 affected. For regimen 2, the acupuncture group lists 3 at risk and 0 affected, and the no-acupuncture group lists 2 at risk and 0 affected. The same at-risk and affected counts are listed for other adverse events in these groups.
For regimens 3 and 4, both assignment groups list 0 at risk and 0 affected for serious and other adverse events. These entries do not describe a comparison of adverse-event risk for those regimens, because no patients are listed as at risk. Death counts are null in the registry, which means they are not reported as numeric counts; null should not be interpreted as zero. No serious adverse-event terms are listed.
These are registry entries, not proof that no adverse events occurred across all study participants or treatment periods. The event definitions, observation window, completeness of safety reporting, and reasons for the zero at-risk entries are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized comparison of acupuncture with no acupuncture during chemotherapy for breast cancer symptoms. It also documents a planned longitudinal analysis of MDASI scores. But the registry states that the 10 enrolled patients were not analyzed because completed enrollment numbers were not met. The record therefore does not provide a primary outcome estimate.
Without analyzed scores, there is no reported treatment difference to describe as larger or smaller, and no confidence interval to indicate its precision. There is also no p-value to assess against the stated significance threshold of 0.003. The hypothesis that scores would be lower with acupuncture remains a hypothesis in the registry summary, not a demonstrated result.
These missing results should not be interpreted as evidence that acupuncture and control were equivalent, nor as evidence that one group had better or worse symptom scores. A conclusion about the comparative symptom outcomes would require analyzed measurements and an estimate with appropriate uncertainty; neither is reported in the registry record.
The safety entries likewise require careful interpretation. Zero affected is recorded for the groups with patients listed at risk, but regimens 3 and 4 list 0 at risk, and death counts are null. The record does not provide enough information to characterize the completeness of adverse-event ascertainment or to draw broad conclusions about safety.
The most direct conclusion is about the status of the evidence in this record: a planned comparison is described, but an analyzed primary result is absent. The record cannot quantify whether symptom scores differed, how large any difference might have been, or how precisely it could be estimated.
13. Why This Trial Matters Statistically
This trial is statistically important as an example of the distinction between a randomized design and an analyzable result. Random allocation can support a fair comparison when outcome data are collected and analyzed as planned. Here, however, the registry reports that the enrolled patients were not analyzed because completed enrollment numbers were not met. The design alone cannot supply an estimate of the difference in symptoms.
The primary outcome also involves multiple patient-reported symptom items over time. The registry recognizes that the 13 MDASI items are separate rather than a single summed score and states a significance threshold of 0.003 to account for multiple comparisons. This highlights why the outcome definition and multiplicity plan matter: interpreting many symptom-specific tests without considering multiplicity can make isolated findings misleading.
The planned mixed-model approach reflects another relevant issue in longitudinal clinical research. Repeated measurements within a patient are correlated, and follow-up measurements may be missing. A model that accounts for correlation and can use incomplete measurement histories may be useful, but its assumptions and implementation need to be reported. The registry describes the rationale but provides no completed model or results to evaluate.
Finally, the record shows why trial status, enrollment, and analysis reporting must be considered alongside the intervention comparison. The terminated study has no posted primary outcome analysis, so readers cannot distinguish a small effect from a large uncertain effect or no difference. That limitation is not resolved by the planned methods or the safety counts.
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.
The central limitation is the absence of an analyzed primary outcome. The registry says the 10 enrolled patients were not permitted to be analyzed because completed enrollment numbers were not met. It does not report a symptom estimate, confidence interval, p-value, or completed analysis population. The reason the trial was terminated and the enrollment target are not reported in the registry record.
Enrollment was 10, but the record does not report how many patients completed treatment, how many contributed MDASI data, or how measurements were distributed over the 15-month timeframe. The status of missing measurements and the intended handling of withdrawals are not reported. These omissions prevent assessment of follow-up completeness and the planned mixed-model assumptions.
The study was unmasked. The registry describes self-reported symptoms and a planned visual inspection of scores, but provides no results or details on procedures intended to address possible reporting or assessment effects. The full acupuncture schedule is not available in the truncated arm descriptions. The record also does not report the particular chemotherapy regimen allocation across enrolled patients.
The planned model is described in general terms, but its final specification, covariance structure, covariates, diagnostics, and any changes from the plan are not reported. The safety record includes null death counts and zero at-risk entries for regimens 3 and 4; event definitions and the safety observation window are also not reported. These limitations leave the posted record unable to support a precise estimate of comparative symptoms or a broad assessment of safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients — NCT01996410.
- Registry record last updated 2016-11-21; status last verified 2016-09.
- Results first posted 2016-11-21.
- 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
NCT01996410 is a randomized, parallel-group, unmasked trial sponsored by OhioHealth, comparing acupuncture with no acupuncture during chemotherapy for breast cancer stages I through III. The registry lists enrollment of 10, a start date of 2013-11, primary completion in 2015-01, and terminated status.
The primary outcome was MDASI scores for chemotherapy-associated symptoms over a timeframe of 15 months. The registry describes planned visual inspection and linear mixed-model comparisons, with a significance threshold of 0.003 for the 13 separate MDASI items. It states that the enrolled patients were not analyzed because completed enrollment numbers were not met. No primary outcome estimates or inferential results are reported.
Safety counts are listed by regimen and assignment, with zero affected in groups that list patients at risk. Regimens 3 and 4 list 0 at risk, and death counts are null. The reason for termination, the enrollment target, and further details of the analysis population are not reported in the registry record.