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 Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer (NCT02486796), a randomized phase 1, phase 2 study. The primary outcome is Subject Reported Quality of Life Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02486796 |
| Phase | Phase 1, Phase 2 |
| Condition | Quality of Life |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Midwestern Regional Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Women receiving neoadjuvant chemotherapy for breast cancer. The registry record describes quality of life as the study’s focus and reports enrollment of 5 participants.
Intervention
Reishi mushroom extract, Coenzyme Q10 and Melatonin, started with Cycle 1 Day 1 of prescribed chemotherapy and continued during treatment.
Comparator
The same three products, started with Cycle 3 Day 1 of prescribed chemotherapy. The registry record calls this the delayed-dosing arm.
Primary question
How did subject-reported quality-of-life scores change over study visits in the immediate and delayed dosing groups? A between-group result or analysis addressing that question is not reported in the registry record.
The comparison concerns the timing of the three products alongside chemotherapy, rather than different products in the two arms. Both groups were assigned the same listed interventions; the registry descriptions distinguish them by when dosing began.
The study also listed inflammatory and immunologic measures in its stated purpose. The secondary outcomes named in the record are serum C-reactive protein, circulating tumor cells in blood, and erythrocyte sedimentation rate. The primary endpoint, however, was a self-administered quality-of-life questionnaire. The registry record does not report outcome analyses for either the primary or secondary measures.
Because quality of life was scheduled repeatedly, the clinical question includes changes over time as well as any difference between the dosing schedules. No single comparison across the scheduled visits is identified in the registry record. That means the record does not establish whether the arms differed at a particular visit, in their overall course, or in the change from the initial visit.
3. Trial Design
This was a randomized, open-label, parallel-group study listed as Phase 1 and Phase 2. The registry record reports enrollment of 5 participants and a terminated status. The start date was 2016-02-19, and the primary completion date was 2017-03-03. A reason for termination is not reported in the registry record.
Participants were assigned to immediate and continuous dosing or delayed dosing. In the immediate arm, Reishi mushroom extract, Coenzyme Q10 and Melatonin began with Cycle 1 Day 1 of prescribed neoadjuvant chemotherapy. In the delayed arm, the same products began with Cycle 3 Day 1. The record does not report whether the assigned schedules were followed by every participant or provide adherence information.
Masking was listed as none. In general, an open-label design means that treatment assignment is not masked from participants or study personnel. For a self-reported endpoint, knowledge of assignment can be relevant to how participants report symptoms or impacts on activities; that is a general design consideration, not evidence that reporting was affected in this study.
The primary outcome was assessed at an initial visit and at study visits scheduled at 3-week intervals up to 4 months. The record also names three secondary outcomes relating to inflammation or circulating tumor cells. Although it lists 4 outcome measures, it reports 0 analyses. Details such as the randomization procedure, allocation concealment, eligibility criteria, sample-size justification, protocol deviations and reasons for the terminated status are not reported in the registry record.
The small enrollment is important context for interpreting the record: the reported arm counts are 3 for immediate dosing and 2 for delayed dosing. These are the numbers at risk in the adverse-event listing; the registry record does not provide a full participant-flow account or clarify whether the same counts apply at every quality-of-life visit.
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 | Immediate and Continuous Dosing | Delayed Dosing |
|---|---|---|
| STARTED | 3 | 2 |
| COMPLETED | 1 | 1 |
| NOT COMPLETED | 2 | 1 |
Reasons for not completing this period:
| Reason | Immediate and Continuous Dosing | Delayed Dosing |
|---|---|---|
| Withdrawal by Subject | 1 | 1 |
| Physician Decision | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: One subject in the 'Delayed' arm withdrew consent following Study Visit 2. One subject in the 'Immediate' arm did not complete the Quality of Life Questionnaire at Visit 2. One subject in the 'Delayed' arm did not complete the Quality of Life Questionnaire at Visit 5. One subject in the 'Immediate' Arm withdrew consent prior to completing Visit 5.
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 | Immediate and Continuous Dosing | Delayed Dosing | Total |
|---|---|---|---|---|
| Participants analysed | 3 | 2 | 5 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 | 2 | 5 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 3 | 2 | 5 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 2 | 5 |
| 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 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 3 | 2 | 5 |
| 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 | 3 | 2 | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Subject Reported Quality of Life Score, measured over Initial visit and study visits at 3-week intervals up to 4 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was the subject-reported Quality of Life Score, measured in units on a scale. Participants completed a self-administered questionnaire using a 0 to 10 Likert scale, with 0 defined as No Effect and 10 as Worst Effect. Items covered symptoms and effects on activities, including pain, fatigue, nausea, sleep disturbance, distress, shortness of breath, memory or recall problems, appetite, drowsiness, dry mouth, sadness, vomiting, numbness, general activities, mood, work, relationships, walking and enjoyment.
The endpoint was summarized as a mean with standard deviation. In general, a mean describes the average observed score, while a standard deviation describes how spread out individual scores are around that average. These summaries can help characterize the scores within a group, but they do not by themselves show whether groups differ or whether a difference is statistically distinguishable from chance.
Quality of life can capture participants’ reported experience during treatment, including symptoms and effects on daily activities. Repeated assessment can describe how scores vary over the course of study visits. The registry record specifies an initial visit and visits at 3-week intervals up to 4 months, but it does not report the actual scores or a result comparing the dosing schedules. It also does not identify a single visit or change-from-baseline measure as the sole primary comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and a quality-of-life endpoint, but it does not provide outcome analyses. It lists 0 analyses. No group means, standard deviations by visit, between-group estimates, confidence intervals or p-values are reported in the registry record. Therefore, the record does not quantify the observed quality-of-life course or the precision of any comparison between immediate and delayed dosing.
There is also no reported result for the secondary measures: serum C-reactive protein, circulating tumor cells in blood, and erythrocyte sedimentation rate. The stated purpose refers to immunologic and/or inflammatory parameters and quality of life, but a purpose statement is not evidence of a measured effect. Without posted outcome values or analyses, no direction or magnitude of a difference can be described.
The primary outcome was assessed repeatedly, at an initial visit and study visits scheduled at 3-week intervals up to 4 months. A repeated schedule can produce several possible summaries: scores at individual visits, change over time within each arm, or a comparison of the trajectories between arms. The registry record does not report which of these, if any, was analyzed. It explicitly notes that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, the record does not support treating any one visit as the definitive comparison.
The enrollment of 5 participants and the arm counts of 3 and 2 place a strong limit on how much can be inferred from the available description. Even if numerical summaries were available, estimates from such a small group would generally be imprecise; this is a general statistical consideration. Here, there are no posted estimates with which to assess that precision. The missing outcome analyses cannot be replaced by the randomized design or by the description of intended measurement.
The sample-size planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The illustration is not the trial’s design justification. No observed primary-outcome effect or corresponding comparison is reported in the registry record, so the record does not provide a basis for interpreting a particular planning estimate as evidence about the study result. Any such illustration should be understood as planning, not as observed power or an outcome finding.
The appropriate reading is therefore descriptive and limited: the record documents the intended comparison, outcome schedule, listed enrollment and safety counts, but does not report analyzed efficacy or quality-of-life results. Statistical significance, the size of any between-arm difference, and the consistency of any effects across visits are not reported in the registry record.
9. Statistical Methods Explained
The registry record describes a randomized, parallel-group study with no masking. Randomization is generally used to make assigned groups comparable on average with respect to factors that could affect outcomes. It does not guarantee balance in a very small study, and it does not remove the need to report how randomization was performed. The specific randomization method and any allocation-concealment procedure are not reported in the registry record.
In a parallel-group design, participants are assigned to one study arm and followed under that assignment. Here, the intended contrast was when the same listed products began: Cycle 1 Day 1 in the immediate and continuous arm versus Cycle 3 Day 1 in the delayed arm. The record lists masking as none. In general, masking can reduce the influence of treatment knowledge on behavior, assessment or reporting. Because the primary endpoint was self-reported, awareness of assigned timing is a relevant consideration, although the record does not establish that it changed responses.
The endpoint is continuous and was specified as a mean with standard deviation. In general, the mean is a measure of the center of observed scores. The standard deviation describes the spread of scores around that mean. A mean and standard deviation can describe each group at a visit, but a comparison requires an estimated contrast and its uncertainty. The registry record provides no endpoint values, contrasts, confidence intervals or p-values.
A confidence interval is a range of values compatible with the data under a statistical model and reflects uncertainty in an estimate. Narrower intervals indicate greater precision, while wider intervals indicate less precision. This is a general explanation; no confidence interval for the quality-of-life endpoint is reported in the registry record. With enrollment of 5, any estimated contrast would warrant particular caution because small datasets typically provide limited precision, but no estimate is available to assess.
The repeated outcome schedule presents an analysis choice. General approaches to repeated measurements can compare groups at each visit, model the pattern across visits, or summarize change over time. These approaches answer related but distinct questions. Repeated scores from the same participant are usually correlated, so an analysis should account for that within-participant dependence rather than treat every score as independent. The registry record does not report the statistical model, the primary visit-level contrast, or how repeated measurements were handled.
Dispersion also matters. In general, over-dispersion means the observed variability is greater than a model expects; if not accounted for, uncertainty estimates can be too optimistic. That concept may be relevant for some types of data, but the record does not report a model or any evidence of over-dispersion in this study. The quality-of-life endpoint was described using a mean and standard deviation, and no actual distributional summaries are reported.
The sample-size assumptions are described as a planning illustration based on an observed effect, not as the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. For non-time-to-event outcomes, the illustration is expressed as participants per arm; time-to-event illustrations are expressed as total events. These are general planning quantities rather than observed study results. The registry record does not report a sample-size justification, and it provides no analyzed primary effect from which to judge the illustration in relation to an observed result.
Multiplicity arises when multiple outcomes, visits or statistical comparisons are examined. In general, making many inferences can increase the chance that at least one appears noteworthy by chance. The quality-of-life outcome included multiple visits, and the record lists three secondary outcomes. The analysis plan for handling multiple comparisons is not reported in the registry record. Without such information or posted analyses, it is not possible to determine how multiplicity was addressed.
Finally, statistical interpretation depends on the analysis population and the handling of missing observations. Common approaches include analyzing participants according to their randomized assignment or analyzing only those with observed outcome data, but the registry record does not state which approach was used. The listed omissions and withdrawal make this uncertainty material. No method for missing data, sensitivity analysis, or prespecified statistical analysis plan is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint was scheduled at multiple visits, and the registry record names three secondary outcomes in addition to the quality-of-life measure. Multiple visits and outcomes create several possible comparisons. In general, testing many comparisons can increase the chance of a chance finding, so a statistical plan may specify a primary comparison or a method for controlling multiplicity. The registry record does not report a multiplicity strategy, a hierarchy of outcomes, or a single primary visit-level contrast. It notes that the primary outcome has several categories or time points and was not reduced to one comparison.
Missing quality-of-life information is specifically noted. One subject in the delayed arm withdrew consent following Study Visit 2. One subject in the immediate arm did not complete the Quality of Life Questionnaire at Visit 2, and one subject in the delayed arm did not complete it at Visit 5. The population description also ends with an incomplete statement about one subject in the immediate arm; further details are not reported in the registry record. These entries do not establish how missing scores were handled in any analysis.
In general, missingness can affect both the amount of information available and the interpretation of observed scores. A complete-case analysis, imputation, or a repeated-measures model may make different assumptions about missing data. The method used, any assumptions about why data were missing, and any sensitivity analyses are not reported in the registry record. The analysis population is also not reported. As a result, the record does not clarify whether participants were analyzed as randomized or whether analyses included only observed questionnaires.
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 |
|---|---|---|---|
| Immediate and Continuous Dosing | 0 | 3 | 0.0% |
| Delayed Dosing | 0 | 2 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Immediate and Continuous Dosing | 0 of 3 |
| Delayed Dosing | 0 of 2 |
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 |
|---|---|
| Immediate and Continuous Dosing | 0 of 3 |
| Delayed Dosing | 0 of 2 |
The registry record lists no serious adverse events among participants at risk in either arm: 0 of 3 in the immediate and continuous dosing arm and 0 of 2 in the delayed dosing arm. It also lists 0 other adverse events in each arm and 0 deaths in each arm. No serious adverse-event terms are listed.
These counts describe the safety information recorded for this study; they are not proof that no adverse events occurred beyond what was captured or reported. The small enrollment limits the amount of safety information that can be observed. In general, a count of zero in a small group cannot rule out uncommon events, and it does not establish that a regimen is safe. The registry record does not provide further detail about adverse-event collection, severity grading for non-serious events, follow-up duration for safety, or attribution of events to study products or chemotherapy.
The arm counts in the safety listing should be read as the participants at risk for the reported safety categories, not as outcome efficacy estimates. They do not provide evidence about quality of life or the secondary laboratory measures. No comparative safety analysis is reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, open-label, parallel-group study was intended to compare starting Reishi mushroom extract, Coenzyme Q10 and Melatonin with Cycle 1 Day 1 of neoadjuvant chemotherapy against starting the same products with Cycle 3 Day 1. It identifies subject-reported quality of life as the primary outcome and names three secondary outcomes. It also records enrollment of 5 participants and a terminated status.
The posted information does not establish what happened to the quality-of-life scores in either arm. No numerical outcome results or analyses are reported in the registry record. There is therefore no reported estimate of a difference between schedules, no uncertainty interval for such a difference, and no p-value by which to assess a statistical comparison. No conclusion about the direction or size of an effect can be drawn from the endpoint description alone.
The same distinction applies to the listed secondary outcomes. Naming C-reactive protein, circulating tumor cells and erythrocyte sedimentation rate as measures does not tell readers whether those measures changed or differed between groups. The registry record does not report their analyses.
In general, a statistically significant result would not by itself establish that a difference is important to participants, while a non-significant result would not establish equivalence or absence of an effect. Neither kind of result is reported. The small enrollment and missing questionnaire information further limit what could be inferred, even if group summaries were available.
The safety listing reports zero serious adverse events, zero other adverse events and zero deaths in both arms, among the participants listed at risk. These are counts, not a comprehensive demonstration of safety. The record supports describing what was registered, but not a judgment that either dosing schedule changes quality of life, inflammatory measures, or safety outcomes.
13. Why This Trial Matters Statistically
This study raises a statistical question that is common in clinical research: how to distinguish a timing comparison from a comparison of different interventions. Both arms were assigned the same three products, with the recorded distinction being whether they began at Cycle 1 Day 1 or Cycle 3 Day 1 of chemotherapy. Clear description of the timing contrast is important when interpreting what an estimated difference would represent.
The quality-of-life endpoint was planned across repeated visits. Such data can describe a trajectory, but the analysis must define which aspect of the trajectory is the main question. A contrast at one visit, an overall difference across visits, and a difference in change over time are not interchangeable. The registry record does not report a single analysis addressing these possibilities, making the absence of results especially important to note.
The record also illustrates why outcome collection and outcome analysis are separate parts of a study. It identifies the questionnaire, scale, symptom domains and schedule, but provides no analyzed score results. In general, an endpoint definition helps readers understand what was intended to be measured; it does not substitute for estimates, uncertainty intervals or an account of missing data.
Finally, the small enrollment and the noted missing questionnaires underscore the importance of reporting participant flow, analysis populations and methods for incomplete repeated measurements. Those details help readers assess how much information supports a result and which assumptions shape it. Since the registry record lists 0 analyses, the available information is useful for understanding the design and reporting gaps, not for estimating comparative effects.
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 registry record reports enrollment of 5 participants and a terminated status, but does not state why the study was terminated. The arm counts in the safety listing are 3 and 2. These numbers provide very little information for estimating differences or assessing precision, and the record does not provide outcome estimates that could be evaluated.
The primary outcome was scheduled repeatedly, but no analyzed comparison across visits is reported. The record does not specify a primary time point, a summary of change, or a repeated-measures model. It also does not report the statistical analysis plan, randomization procedure, allocation concealment, sample-size justification or analysis population. These omissions make it difficult to assess whether reported analyses followed prespecified methods; in this case, no analyses are listed.
Missing questionnaire data and a withdrawal are noted, including a quality-of-life questionnaire omission in each arm at specified visits. The population description for the immediate arm is incomplete. Methods for handling missing observations and sensitivity analyses are not reported in the registry record.
The study was open-label, and the primary measure was self-reported. In general, awareness of assignment can be relevant to reporting, although no effect on responses is demonstrated. The record does not provide adherence information or details of adverse-event ascertainment. It lists zero adverse events in the reported categories, but the small enrollment and limited reporting do not support broad safety conclusions.
The registry record describes the planned measures and dosing schedules more fully than it reports results. Without numerical outcome data, the limitations are not merely uncertainty around an effect estimate: the comparative effect itself is unavailable.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer — NCT02486796.
- Registry record last updated 2018-08-01; status last verified 2018-07.
- Results first posted 2018-08-01.
- 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 Phase 1 and Phase 2 randomized, open-label, parallel-group study of naturopathic medicine alongside neoadjuvant chemotherapy for breast cancer. Enrollment was 5, and the record lists the study status as terminated. Immediate dosing began at Cycle 1 Day 1; delayed dosing began at Cycle 3 Day 1. Both arms were assigned Reishi mushroom extract, Coenzyme Q10 and Melatonin.
The primary endpoint was a self-administered quality-of-life score measured at an initial visit and study visits at 3-week intervals up to 4 months. Three secondary outcomes were listed: serum C-reactive protein, circulating tumor cells in blood and erythrocyte sedimentation rate. The record lists 0 analyses and does not report outcome values or comparative results.
The safety listing reports 0 serious adverse events, 0 other adverse events and 0 deaths in each arm. A withdrawal and incomplete questionnaires are noted. The reason for termination, statistical analysis methods and handling of missing data are not reported in the registry record.