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 Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study (NCT02312934), a randomized phase 2 study. The primary outcome is Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02312934 |
| Phase | Phase 2 |
| Condition | Chemo Brain, Chemotherapy-related Cognitive Impairment, Chemo Fog |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Vanderbilt University Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Breast cancer patients described as 1-5 years post chemotherapy, with problems involving attention, learning, and memory. The registry record lists chemo brain and chemotherapy-related cognitive impairment among the conditions.
Intervention
Transdermal nicotine, delivered by patch. The registry describes a titration schedule, but the nicotine-arm schedule is truncated in the record, so its full sequence is not reported there.
Comparator
A matching placebo transdermal patch. The registry says the placebo arm followed the same titration schedule as the nicotine arm.
Primary question
How did the FACT-Cog PCI score change from baseline to 8-Weeks in the nicotine and placebo groups? Higher scores indicate better cognitive functioning.
This is a question about change in a participant-reported measure of perceived cognitive functioning, not a direct test of every cognitive ability. The primary outcome is the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale. Its PCI subscale addresses concerns involving memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability.
The registry describes the study as a pilot evaluation of nicotine patches for cognitive problems after chemotherapy. It records random allocation and quadruple masking, with a parallel design. The key interpretive issue is that the primary outcome has several categories or time points and is not reduced in the registry record to a single comparison. Numerical group results, an estimated difference in change, and its uncertainty are not reported in the registry record. The clinical question can therefore be stated from the protocol description, but the posted record does not support a numerical answer about the between-group result.
3. Trial Design
The registry identifies NCT02312934 as a Phase 2 randomized, quadruple-masked, parallel study. It lists an enrollment of 22 and a completed status. The study was sponsored by Vanderbilt University Medical Center. Its recorded start is 2015-08, and its primary completion is 2018-05.
Participants were assigned to transdermal nicotine or a matching placebo patch. The registry describes the placebo schedule as matching the nicotine schedule. It also states that patches were applied for 16 hours per day and describes nicotine delivery and titration; however, the nicotine-arm schedule is cut off in the record. Details beyond the text recorded there should not be inferred.
The primary outcome was change in the FACT-Cog PCI Scale from baseline to 8-Weeks. The registry also lists the Conners Continuous Performance Test as a secondary outcome and records two outcome measures and two analyses. The record does not provide enough detail to identify the secondary outcome’s numerical results or specify how each analysis was conducted.
Random allocation can help balance measured and unmeasured participant characteristics between groups on average, although it does not guarantee balance in a pilot study. Masking can reduce the influence of expectations on participant reports, care, and assessment, depending on which people were masked and whether masking was maintained. The registry uses the term “quadruple” but does not identify the masked roles in the record. The protocol’s allocation procedure, concealment process, and assessment of masking success are not reported in the registry record.
As a pilot study with an enrollment of 22, the design is best understood as a small randomized comparison. The registry record does not report the sample-size justification or whether the enrollment target was based on a formal power calculation. It also does not give enough information to assess recruitment, adherence, or completion by group.
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.
Before assignment: Of the 106 people pre-screened for the study, 37 attended the initial screening visit. Twenty-two participants met entry criteria and were randomized. Participants that were not randomized were excluded from the study because they did not meet inclusion/exclusion criteria.
Overall Study
| Stage | Transdermal Nicotine | Placebo |
|---|---|---|
| STARTED | 11 | 11 |
| COMPLETED | 9 | 11 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | Transdermal Nicotine | Placebo |
|---|---|---|
| Lost to Follow-up | 1 | 0 |
| Physician Decision | 1 | 0 |
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 | Transdermal Nicotine | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 11 | 22 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 | 11 | 20 |
| Age, Categorical: >=65 years | Participants | 2 | 0 | 2 |
| Age, Continuous | Years | 56.00 (SD 11.58) | 52.55 (SD 7.66) | 54.27 (SD 9.74) |
| Sex: Female, Male: Female | Participants | 11 | 11 | 22 |
| 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 | 11 | 11 | 22 |
| 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 | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 10 | 10 | 20 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 11 | 11 | 25 |
| Cancer Type: Breast Cancer | Participants | 8 | 10 | 18 |
| Cancer Type: Non-Hodgekin's Lymphoma | Participants | 2 | 0 | 2 |
| Cancer Type: Ovarian Cancer | Participants | 0 | 1 | 1 |
| Cancer Type: Colon Cancer | Participants | 1 | 0 | 1 |
| Cancer Stage: Stage I | Participants | 3 | 5 | 8 |
| Cancer Stage: Stage II | Participants | 3 | 4 | 7 |
| Cancer Stage: Stage III | Participants | 4 | 1 | 5 |
| Cancer Stage: Stage IV | Participants | 1 | 1 | 2 |
| Cancer Treatment Received: Chemotherapy | participants | 11 | 11 | 22 |
| Cancer Treatment Received: Surgery | participants | 10 | 11 | 21 |
| Cancer Treatment Received: Radiation | participants | 5 | 7 | 12 |
| Current Endocrine Therapy: Yes | Participants | 6 | 7 | 13 |
| Current Endocrine Therapy: No | Participants | 5 | 4 | 9 |
| Post-Menopausal Status: Pre-Menopausal | Participants | 5 | 6 | 11 |
| Post-Menopausal Status: Post-Menopausal | Participants | 6 | 5 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale, measured over Baseline to 8-Weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale from baseline to 8-Weeks. The registry describes this as a mean on a scale, with standard deviation as the dispersion measure. Change scores are mentioned, but the description of their calculation is truncated. The exact calculation used for the posted endpoint is therefore not reported in the registry record.
The PCI subscale has 20 items, a minimum score of 0, and a total possible score of 72. Higher scores indicate better cognitive functioning. It covers perceived memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability. Because it is a subjective measure, it reflects participants’ reported cognitive concerns rather than serving as a direct measure of every cognitive process.
The registry says the FACT-Cog has been used to monitor subjective complaints related to chemotherapy-related cognitive impairment and describes prior evidence of internal consistency, test-retest reliability, and validity. That rationale explains why a participant-reported scale may be relevant to this study’s question. It does not establish that the scale captures every outcome important to participants, or that any observed score change would necessarily represent a noticeable functional difference.
The record refers to visits at 3-week, 6-week, and 8-week points, while the primary outcome timeframe is listed as baseline to 8-Weeks. Since the primary result is not reduced to one comparison and its numerical values are not reported in the registry record, the magnitude and precision of change cannot be assessed from the posted information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes the study’s comparison and its intended primary measure, but it does not report a single reduced primary comparison. In particular, it gives no numerical group means, change estimates, between-group contrast, confidence interval, or p-value for the primary outcome in the record. The size, direction, and precision of the primary result therefore cannot be described from this record.
This matters because a within-group change and a randomized between-group comparison answer different questions. A group’s score can change over time for many reasons, including time, expectations, measurement variation, and changes shared by both groups. The randomized comparison is generally the more relevant contrast for evaluating whether the groups’ outcome patterns differed. The registry’s multiple categories or time points are not reduced to one primary comparison, so the record does not identify a single estimate to interpret.
The posted outcome format is a mean with standard deviation. A mean describes the average score or change, while the standard deviation describes variability among observations around that average. Neither quantity alone provides the uncertainty around the difference between groups. A confidence interval, when reported, gives a range of values compatible with the data and analysis under its assumptions; it helps show precision, not whether a result is clinically important by itself. No such primary estimate or interval is reported in the registry record.
The study is marked completed and lists an enrollment of 22, but those details do not establish how many participants contributed to the primary analysis. The analyzed group sizes, missing outcome data, and reasons for missingness are not reported in the registry record. Without these details, it is not possible to assess the extent to which the posted comparison, if any, represents all randomized participants.
The registry describes sample-size calculations as planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such calculations are prospective planning aids, not observed power and not evidence that a study detected a meaningful difference. The numerical planning results are not reported in the record. Nor does the registry report the original sample-size justification.
The adverse-event record lists zero serious events among 11 at risk in each group, and no deaths in either group. It lists other adverse events affecting 7 of 11 in the nicotine group and 8 of 11 in the placebo group. These counts are descriptive. They do not, on their own, establish comparative safety, identify the types or severity of the other events, or show whether an event was caused by treatment. The registry does not list serious-event terms.
Overall, the record supports a description of the trial’s design, endpoint, and recorded adverse-event counts. It does not support a numerical conclusion about the primary between-group effect or its precision. No treatment benefit or lack of benefit should be inferred from the absence of a reduced result in this record.
9. Statistical Methods Explained
General explanation: A randomized parallel-group study assigns participants to separate intervention groups and compares outcomes between them. Randomization aims to make the groups comparable on average at the point of assignment. It does not ensure that all characteristics will be balanced, especially in a small study, and it cannot prevent later differences in adherence, follow-up, or missing data. The registry describes this trial as randomized and parallel but does not report the sequence-generation or allocation-concealment methods.
What does masking contribute?
General explanation: Masking is intended to limit the influence of knowledge about assigned treatment on expectations, behavior, outcome reporting, and assessment. A matching placebo can help make treatment assignment less apparent to participants, but the record does not establish whether masking was successful. The registry labels the study quadruple-masked but does not identify the masked roles in the record. The degree to which masking reduced bias therefore cannot be evaluated from this information alone.
What does a mean and standard deviation describe?
General explanation: A mean is a measure of the average observed score or change. A standard deviation describes how spread out individual observations are around that mean. These summaries are useful for describing a continuous outcome, but they do not by themselves provide a treatment-effect estimate or its precision. A comparison should specify the contrast of interest, such as a difference between groups in change from baseline, and report uncertainty around that contrast. The registry identifies the primary outcome as a mean with standard deviation, but the primary numerical summaries and between-group estimate are not reported in the registry record.
Why does the choice of comparison matter?
General explanation: Comparing change within each group is not equivalent to comparing the groups. A within-group change can reflect factors that affect both groups, including time and repeated measurement. A between-group contrast is designed to distinguish outcome patterns between randomized groups, subject to the analysis assumptions and limitations. The registry states a baseline-to-8-Weeks primary timeframe, but its primary outcome has several categories or time points and is not reduced to one comparison. The exact contrast and its calculation are not reported in the registry record.
How should uncertainty be read?
General explanation: A confidence interval expresses the precision of an estimate under a specified statistical model and its assumptions. A wide interval indicates that a range of effects remains compatible with the data; a narrow interval indicates greater precision. The interval does not itself establish clinical importance, and it should be interpreted alongside the estimate, outcome scale, and study design. A p-value addresses compatibility with a specified null model, not the probability that a treatment works or the size or importance of an effect. The registry record does not report a primary confidence interval or p-value for a single reduced comparison.
General explanation: With continuous outcomes, model choice can depend on the outcome distribution, study design, and analysis objective. Approaches may compare final scores, changes, or repeated measurements, and can adjust for baseline values. Each approach involves assumptions and may target a different estimand. The record does not state which model or adjustment strategy was used for the posted primary analysis. It would be inappropriate to infer one from the mean-and-standard-deviation format alone.
What does multiplicity mean?
General explanation: When an analysis considers multiple outcomes, time points, or comparisons, the chance of at least one apparently unusual result can increase if each is assessed independently without adjustment. An analysis plan may designate a primary comparison or account for multiplicity through an appropriate method. The registry indicates that the primary outcome has several categories or time points and is not reduced to one comparison. The statistical plan for handling these possibilities is not reported in the registry record, so it is not possible to determine whether or how multiplicity was addressed.
Why do missing data and analysis populations matter?
General explanation: Missing outcome measurements can reduce precision and can bias a comparison if their absence is related to outcome or treatment. The consequences depend on how much information is missing, why it is missing, and the analysis method. An intention-to-treat analysis generally preserves randomized assignment when analyzing participants, while other analysis populations may exclude participants according to specified criteria. The registry record does not report the numbers analyzed, missing-data handling, or the analysis population definition. The randomized enrollment count alone cannot establish any of these details.
The registry describes sample-size calculations as planning illustrations using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. These are planning assumptions, not a report of the trial’s original design justification. Planning sample sizes are not observed power. The numerical planning outputs and the original sample-size justification are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is described as having several categories or time points, and the registry does not reduce it to one comparison. The statistical plan for choosing among these measurements, defining a primary contrast, or adjusting for multiple comparisons is not reported in the registry record. The record lists two outcome measures and two analyses, but does not explain how those analyses relate to outcomes, time points, or multiplicity control.
Consequently, the posted record does not identify a single primary estimate whose statistical significance or precision can be interpreted. Selecting a particular time point or comparison after seeing results can lead to misleading emphasis unless the choice is prespecified or accounted for in the analysis. Whether such choices were prespecified, and whether any adjustment was used, is not reported in the registry record.
The record does not report outcome completeness, participant flow by group, reasons for missing measurements, or the number included in each analysis. It also does not describe imputation, sensitivity analyses, or rules for handling incomplete follow-up. These omissions prevent assessment of whether missing observations could have affected the reported results.
Randomization describes assignment, not necessarily the population analyzed. The registry record does not define an intention-to-treat or other analysis population, and it does not state whether participants were analyzed according to assigned group. The enrollment count should therefore not be treated as the number contributing data to the primary endpoint. Without analysis-population and missing-data details, the robustness of any outcome comparison cannot be evaluated from the registry 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 |
|---|---|---|---|
| Transdermal Nicotine | 0 | 11 | 0.0% |
| Placebo | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Transdermal Nicotine | 0 of 11 |
| Placebo | 0 of 11 |
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 |
|---|---|
| Transdermal Nicotine | 7 of 11 |
| Placebo | 8 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Transdermal Nicotine | Placebo |
|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | 6 of 11 | 2 of 11 |
| Gastrointestinal | Gastrointestinal disorders | 3 of 11 | 3 of 11 |
| Neurologic | General disorders | 2 of 11 | 2 of 11 |
| Mood | General disorders | 0 of 11 | 1 of 11 |
| Insomnia | General disorders | 0 of 11 | 1 of 11 |
The registry records zero serious adverse events among 11 participants at risk in the transdermal nicotine group and zero among 11 at risk in the placebo group. It also records zero deaths in each group. No serious adverse-event terms are listed.
For other adverse events, the registry records 7 affected participants among 11 at risk in the nicotine group and 8 among 11 at risk in the placebo group. These are counts of affected participants, not descriptions of the event types, severity, timing, or duration. The record does not provide those details in the information.
These figures are descriptive and should not be interpreted as proof that the groups have equivalent safety profiles or that an event was caused by the assigned patch. With a small pilot study, uncommon events may not be observed, and the absence of recorded serious events does not establish absence of risk. The registry record also does not report a statistical comparison of adverse events or enough detail to assess how events were collected and classified.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, quadruple-masked, parallel pilot study compared transdermal nicotine with a matching placebo patch for post-chemotherapy subjective cognitive complaints. Its primary measure was change in the FACT-Cog PCI Scale from baseline to 8-Weeks. The scale concerns perceived cognitive functioning, with higher scores indicating better functioning.
What the record does not establish is the numerical between-group result. The primary outcome is not reduced to one comparison, and the registry record does not report a single estimate, confidence interval, or p-value that would allow the size, direction, or precision of a primary effect to be assessed. The absence of such a result in the record is not evidence that there was no effect, nor is it evidence of benefit.
The listed enrollment of 22 and completed status describe the study record but do not show how many participants provided endpoint data or were included in an analysis. The record also does not report the original sample-size justification, the statistical analysis plan, missing-data methods, or analysis-population definition. Those gaps limit assessment of how reliably the observed data, if reported elsewhere, would answer the clinical question.
The adverse-event counts show what the registry records for serious events, deaths, and other affected participants. They do not establish causation, exclude uncommon harms, or provide detailed event profiles. Likewise, a planning illustration based on an observed effect is not a substitute for an effect estimate with uncertainty, and is not observed power.
The appropriate conclusion is therefore limited: the registry documents the study design, intended outcome, and certain adverse-event counts, but does not provide a single reduced primary result from which to judge the comparative outcome. Any broader conclusion about treatment efficacy or safety would go beyond the information reported in the registry record.
13. Why This Trial Matters Statistically
This trial raises several useful statistical issues in a setting where the main outcome is subjective. Participant-reported cognitive complaints can capture concerns that matter to participants, while also being influenced by expectations and the experience of taking part in a study. Randomization and masking are design features intended to make a comparison more informative, but their presence does not replace clear outcome reporting.
The study also illustrates why an endpoint needs a clearly defined comparison. The registry identifies change in the FACT-Cog PCI Scale from baseline to 8-Weeks, but describes several categories or time points and does not reduce the primary outcome to one comparison. Without a specified contrast and an estimate with uncertainty, readers cannot tell how the groups differed or how precisely that difference was estimated.
A pilot trial can provide experience with study procedures and generate information for later research. However, the registry record does not report a sample-size justification or enough detail to assess recruitment, retention, adherence, or outcome completeness. The enrollment of 22 alone cannot establish whether the study was designed to estimate an effect precisely or to test a particular hypothesis.
The safety record is also a reminder to distinguish event counts from conclusions. Counts of serious and other adverse events are useful descriptive information, but they do not by themselves establish causality or rule out uncommon events. Statistical interpretation depends on clear definitions, complete follow-up, and transparent reporting of how events were collected.
Overall, the statistical importance of this record lies in the distinction between a well-defined research question and an interpretable result. The question and design are documented, but a single primary estimate, its uncertainty, and essential analysis details are not reported in the registry record.
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 does not provide a single reduced primary comparison, and it does not report the numerical primary outcome results. The description of the change-score calculation is truncated, leaving the precise endpoint definition unclear. The outcome timeframe is baseline to 8-Weeks, while the record also notes intermediate visits; how those measurements were incorporated into the primary analysis is not reported.
The nicotine-arm titration description is truncated, so the full intervention schedule cannot be reconstructed from the record. The placebo description says it followed the same titration schedule, but that does not resolve the missing intervention detail. The record also does not identify the roles covered by quadruple masking or report whether masking was maintained.
Participant flow, group-specific numbers analyzed, adherence, withdrawals, missing outcome data, and reasons for missingness are not reported in the registry record. The original sample-size justification and statistical analysis plan are also not reported. Without these details, the precision, potential for bias from missing observations, and prespecification of the primary analysis cannot be assessed.
The adverse-event information is limited to participant counts for serious and other events and deaths. Serious-event terms are not listed, and the record does not give detailed event descriptions or a comparative statistical analysis. Finally, a small pilot enrollment limits how much can be inferred about uncommon events or the stability of an estimated effect. These limitations constrain interpretation of the registry record and should not be replaced by assumptions about unreported methods or results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study — NCT02312934.
- Registry record last updated 2020-01-21; status last verified 2020-01.
- Results first posted 2020-01-21.
- 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
NCT02312934 is a completed Phase 2 randomized, quadruple-masked, parallel pilot study sponsored by Vanderbilt University Medical Center. It lists an enrollment of 22 and compares transdermal nicotine with a matching placebo patch in breast cancer patients described as 1-5 years post chemotherapy.
The primary outcome is change in the FACT-Cog PCI Scale from baseline to 8-Weeks, with higher scores indicating better cognitive functioning. The registry also lists the Conners Continuous Performance Test as a secondary outcome. The primary outcome has several categories or time points and is not reduced in the registry record to one comparison. Numerical primary results, analysis-population details, and missing-data methods are not reported in the registry record.
The adverse-event record lists zero serious events and zero deaths in each group, and other adverse events affecting 7 participants in the nicotine group and 8 in the placebo group. These counts are descriptive and do not establish causation or comparative safety.