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 A Pilot Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy on Cancer Related Sleep Disturbances in CLL and Breast Cancer Patients Experiencing Fatigue (NCT00792077), a non-randomized phase 2 study. The primary outcome is Total Sleep Time as Measured by Polysomnography (PSG).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00792077 |
| Phase | Phase 2 |
| Condition | Leukemia, CLL |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study summary describes patients with chronic lymphocytic leukemia (CLL) and/or breast cancer who experience fatigue. The registered condition list names Leukemia and CLL, while the sleep-time arm description specifically refers to patients with CLL and severe cancer-related fatigue. The registry record does not report the population details for the primary outcome.
Intervention
The intervention listed is lenalidomide. The arm description pairs lenalidomide with an actigraph, questionnaire, and sleep test. The summary also discusses treatments including radiation therapy, but radiation is not listed as an intervention in the record.
Comparator
No concurrent comparator arm is listed. The study is registered as non-randomized and single-group, so the intended assessment is within the treatment group rather than a randomized comparison between treatment strategies.
Primary question
The primary outcome is total sleep time measured by polysomnography (PSG), recorded in minutes. The stated measure is change between before and after the first cycle of lenalidomide, over a timeframe of up to 8 weeks. The registry record does not report the observed change.
In broad terms, the study asks whether sleep duration changes across an initial treatment period in fatigued patients described as having CLL and/or breast cancer. This is a question about a measured symptom outcome, not a comparison of lenalidomide with an untreated or alternative-treatment group. Because there is no registered comparator arm, any before-and-after change would describe participants' measurements over time; by itself, it would not isolate a treatment effect from other explanations for change.
The registry record also names fatigue, sleepiness, and performance status as secondary outcome areas. The specific result values for these outcomes are not reported in the registry record. The mismatch between the broad study summary and the CLL-specific arm description means the record does not establish how the primary endpoint population relates to the overall population described in the summary.
3. Trial Design
The registry identifies this as a Phase 2, pilot, open-label study with non-randomized allocation and a single-group model. Enrollment is listed as 6, and the study status is completed. The recorded start is 2008-11, and primary completion is recorded as 2020-08-03. The sponsor is M.D. Anderson Cancer Center.
Lenalidomide is the intervention listed in the registry. The sleep-time arm description refers to assessment of patients with CLL and severe cancer-related fatigue using lenalidomide, an actigraph, a questionnaire, and a sleep test. The brief summary describes a broader interest in cytotoxic therapy and/or radiation therapy, including lenalidomide, for sleep problems and fatigue in CLL and breast cancer. However, only lenalidomide appears in the listed intervention, and the registry record does not describe a separate radiation-treatment arm.
The primary endpoint is framed as a before-and-after measurement around the first cycle of lenalidomide, with follow-up up to 8 weeks. There is no listed randomized allocation, masking, or concurrent control group. An open-label, single-group design can document measurements over time, but it cannot provide the same protection against confounding as a randomized comparison. Changes may coincide with treatment without being attributable to treatment alone.
The enrollment figure is a registry entry, not an outcome result and not proof that every enrolled participant contributed a complete primary endpoint. The registry record does not report the number with usable baseline and follow-up PSG measurements, the analysis population, or reasons for missing measurements. It also does not report a protocol-level rationale for the enrollment target. The design is described as a pilot study, but the registry record does not report whether the study was intended primarily for feasibility, estimation, or hypothesis testing.
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 | Lenalidomide |
|---|---|
| STARTED | 6 |
| Day 15+/- 3 Days | 6 |
| Day 29+/-3 Days | 6 |
| Day 43+/-3 Days | 6 |
| Day 57+/-3 Days | 6 |
| COMPLETED | 6 |
| NOT COMPLETED | 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 | Lenalidomide |
|---|---|---|
| Participants analysed | 6 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 6 |
| Marital Status: Divorced | Participants | 2 |
| Marital Status: Married | Participants | 3 |
| Marital Status: Separated | Participants | 1 |
| Employment Status: Full Time | Participants | 2 |
| Employment Status: Medical Leave | Participants | 1 |
| Employment Status: Part time | Participants | 1 |
| Employment Status: Unemployed | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Total Sleep Time as Measured by Polysomnography (PSG), measured over before and after 1st cycle of Lenalidomide treatment, up to 8 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | Minutes |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is total sleep time measured by polysomnography (PSG), in minutes. PSG is an instrument-based sleep assessment; in this study, the registry describes the outcome as the change in total sleep time from before to after the first cycle of lenalidomide, with the timeframe extending up to 8 weeks. The registered summary statistic is the median, with inter-quartile range as the dispersion measure.
Sleep duration is used as a measurable aspect of cancer-related sleep disturbance. It complements subjective reports, which can capture a participant's experience but may not describe sleep duration in the same way as an instrument-based assessment. The arm description also lists an actigraph and questionnaire, though the registry record does not explain their specific roles in the primary endpoint calculation.
For a before-and-after endpoint, the key result would ordinarily describe how participants' sleep-time measurements changed across the specified assessment period. Reporting a median and inter-quartile range can convey the central observation and the spread of observations without assuming that the distribution is symmetric. The registry record does not report the median change, its inter-quartile range, participant-level measurements, or an uncertainty interval. Therefore, the endpoint definition is available, but the magnitude and precision of the observed change are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a clinically relevant measurement question but does not provide the primary endpoint result. It identifies PSG total sleep time in minutes, evaluated as change before and after the first cycle of lenalidomide, up to 8 weeks. It also specifies median and inter-quartile range as the summary approach. Without the observed median change and its spread, the direction, magnitude, and variability of the sleep-time findings cannot be described.
The record lists 0 analyses. The primary outcome is named, but no numerical outcome result or inferential analysis is reported in the registry record. An estimate such as a mean or median change, a confidence interval, or a p-value is not reported in the registry record. The absence of those values means statistical precision cannot be assessed. It also means the registry record cannot establish whether any observed change was small or large relative to the natural variability of sleep measurements.
Even if a before-and-after change were available, the design would require cautious interpretation. In a single-group study, each participant's later measurement can be compared with that participant's earlier measurement, but there is no concurrent control group to estimate what might have happened over the same period without the intervention. Time trends, changes in symptoms, other care, measurement variation, and regression toward typical values can contribute to an observed change. These are general considerations for single-group before-and-after studies, not findings established for this trial.
The summary describes interest in CLL and breast cancer, while the arm description focuses on CLL, and the condition list names Leukemia and CLL. The primary outcome population field is not completed in the registry record. This leaves uncertainty about which participants the endpoint represents and how broadly a result could be applied across the populations named in the summary.
The listed secondary outcomes include the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale Score, Epworth Sleep Scale, and ECOG Performance Status. The record reports 4 outcome measures overall, but does not give results for these measures. Their names indicate areas the study intended to assess; they do not establish that scores improved, worsened, or remained unchanged.
Overall, the record supports a description of the planned measurement and study structure, but not a quantitative conclusion about change in sleep time or fatigue. A missing result should not be interpreted as evidence of no change. Nor should the completed status or the enrollment entry be treated as evidence that the primary outcome was analyzed or that a particular conclusion was reached.
9. Statistical Methods Explained
What does a median with an inter-quartile range describe?
General explanation: The median is the middle value when observations are ordered. The inter-quartile range describes the spread of the central portion of those observations. These summaries can be useful when a distribution is skewed or when a few extreme observations could pull an average away from the values typical of the group. A median and inter-quartile range describe the data's location and spread; they do not by themselves quantify uncertainty about an underlying treatment effect.
For this study, the registered parameter is median and the dispersion measure is inter-quartile range. The record does not report the actual median change or range. It is also not clear from the registry entry whether the summaries would be calculated from individual changes or from separate before-and-after distributions. That distinction matters: a distribution of participant-level changes directly describes within-person change, while separate summaries at each time point do not show how each person's measurements paired across time.
What does a before-and-after design estimate?
General explanation: A paired before-and-after analysis uses repeated measurements from the same people. Pairing can account for stable differences between participants because each person serves as their own reference. However, it does not control for factors that change over time, and it does not supply the counterfactual outcome that a concurrent comparison group is intended to represent. Without a control group, an observed temporal change cannot be attributed to the intervention with the confidence that a well-conducted randomized comparison can support.
The endpoint description specifies measurements before and after the first cycle, with a timeframe of up to 8 weeks. The registry record does not report the exact measurement schedule, rules for timing PSG assessments, or how deviations from the intended schedule were handled. It does not report whether analysis used paired observations or another method. These details are important to interpreting a longitudinal estimate, but are not reported in the registry record.
Why does uncertainty matter?
General explanation: An estimate is more informative when accompanied by a measure of uncertainty. A confidence interval gives a range of values compatible with the data and the model's assumptions at a stated confidence level. It helps readers assess how precisely an effect has been estimated. A p-value, when reported, addresses compatibility with a specified null hypothesis under the analysis assumptions; it does not show the probability that the null hypothesis is true, and it does not measure clinical importance.
No confidence interval, p-value, or other inferential result is reported for the primary outcome in the registry record. With the endpoint result itself absent, statistical uncertainty and the compatibility of the data with different possible changes cannot be assessed. General statistical concepts cannot fill in that missing information.
How should a small pilot study be read?
General explanation: Pilot studies often offer preliminary information about procedures, measurement, and possible outcome patterns. Small studies can produce estimates with substantial uncertainty, and estimates may be sensitive to individual observations. A pilot label alone does not reveal the study's intended decision rule or establish that it was powered for a definitive efficacy comparison. The registry record does not report the sample-size justification or a prespecified analysis plan.
The record lists enrollment as 6. It does not report how many participants had evaluable paired PSG measurements. Enrollment and analysis counts can differ when participants lack one of the required measurements or otherwise do not contribute to an endpoint analysis. No such reasons or participant flow are reported in the registry record.
What do the planning illustrations mean?
General explanation: A sample-size calculation is a planning exercise that depends on assumptions about the effect to detect, variability, significance level, allocation, and statistical model. The assumptions stated for the planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is expressed as a stated fraction of an observed effect. Time-to-event illustrations use a total number of events, while other illustrations use participants per arm.
Those assumptions do not describe the registered study design, which is non-randomized and single-group. The illustrations are not observed power, do not demonstrate that the trial had a particular probability of detecting an effect, and are not evidence that the design was justified in advance. The registry record does not report the trial's own sample-size justification. No planning value should be treated as a trial outcome or as a substitute for an uncertainty interval around the primary endpoint.
What role could measurement variation play?
General explanation: Sleep measurements can vary within a person from one assessment to another. Measurement conditions, day-to-day variability, and the timing of assessments can affect observed values. Repeated assessments and consistent procedures can help characterize variability, but their adequacy depends on details of the protocol and the data. The registry record names PSG and an actigraph but does not describe measurement quality procedures, adherence, or repeatability.
These considerations explain why an endpoint definition alone is not enough to judge the strength of a result. The numerical estimate, its uncertainty, the analyzed population, and the handling of missing measurements would all be needed for a fuller statistical assessment. Those results and details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 4 outcome measures, including total sleep time as the primary outcome and secondary measures concerning fatigue, sleepiness, and performance status. When a study assesses multiple outcomes, the chance of observing at least one apparently notable result can increase if each is tested separately without accounting for the family of analyses. General explanation: Multiplicity procedures can control error rates or distinguish a primary confirmatory question from exploratory assessments.
The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or a statistical analysis plan explaining how multiple outcomes would be interpreted. It lists 0 analyses, and no outcome-specific numerical results are reported in the registry record. It is therefore not possible to determine whether any multiplicity approach was planned or used.
The record also does not report missing-data counts or methods, the number of participants with complete paired PSG measurements, or the analysis population. General explanation: Missing follow-up data can affect a before-and-after estimate if the participants with measurements differ systematically from those without them. The direction and extent of that concern depend on the amount, reasons, and pattern of missingness, as well as the analysis method.
There is no reported description of how participants were included in each outcome analysis, how incomplete measurements were handled, or whether any sensitivity analyses were performed. These items are not reported in the registry record. Consequently, the record does not support an assessment of the robustness of endpoint estimates to missing data or multiple outcome testing.
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 |
|---|---|---|---|
| Lenalidomide | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Lenalidomide | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Lenalidomide | 0 of 6 |
The registry safety entry lists the Lenalidomide group with 6 at risk for serious adverse events and 0 affected. For other adverse events, it lists 6 at risk and 0 affected. Deaths are listed as 0. No top serious adverse-event terms are listed.
These are the figures recorded for the study group; they do not provide event descriptions, timing, severity gradations beyond the serious-versus-other classification, or a comparison with another group. The record does not explain the safety collection window or provide a narrative account of monitoring. The listed figures should therefore be read as registry-reported counts, not as proof that treatment carries no risk or that no unrecorded event occurred.
General explanation: A zero recorded count in a small study does not establish that an event is impossible or that its true frequency is zero. Safety interpretation also depends on how events were defined, collected, and followed, and on the amount of exposure and observation. The registry record does not report those details beyond the listed at-risk figures and event counts.
12. What the Result Does, and Does Not, Mean
The study's registered objective concerns sleep disturbance and fatigue in patients described as having CLL and/or breast cancer. Its primary measure is PSG total sleep time, assessed before and after the first cycle of lenalidomide over up to 8 weeks. The record identifies a pilot, open-label, non-randomized, single-group design. It therefore provides context for what was intended to be measured, but the registry record does not report the observed primary endpoint result.
Without the median change and inter-quartile range, there is no basis in the registry record for describing the size or direction of a change in sleep time. Without an uncertainty interval or inferential result, its precision cannot be judged. Missing numerical results do not mean that no change occurred; they mean that the posted record does not allow the change to be quantified.
Even a reported pre-to-post change would not, on its own, show that lenalidomide caused the change. The single-group design has no concurrent control arm, and the record does not report methods that could resolve alternative explanations for change over time. This is a general limitation of interpreting uncontrolled before-and-after comparisons, not a claim about what happened to participants in this study.
The record names secondary measures related to fatigue, sleepiness, and performance status, but gives no values for them. It also does not report participant-level data, missing-data handling, or the analyzed population. The condition and arm descriptions differ in scope, and the primary outcome population is not specified in the registry record, which further limits interpretation of the population represented by any potential endpoint result.
Thus, the record establishes the study question, design, outcome definition, and safety counts. It does not establish whether sleep time or other symptoms changed, how precisely any change was estimated, or whether any change was due to the intervention. Those conclusions require outcome and analysis details not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable as a pilot study asking a symptom-focused question with an instrument-based sleep measure. It connects a before-and-after assessment of PSG total sleep time with other registered measures of fatigue, sleepiness, and performance status. Looking at different dimensions of symptom experience can be informative because a sleep-duration measure and a self-reported symptom score do not necessarily capture the same aspect of a patient's experience. The registry record, however, does not report results for these outcomes.
The design also illustrates the distinction between describing change and estimating a causal treatment effect. Repeated measurement within one group can describe how measurements differ over time, but without a concurrent comparator it cannot separate treatment-associated change from other temporal influences. That distinction matters especially when the goal is to interpret symptom change, which may reflect several factors. This is a general methodological point, not a finding about the participants in this study.
Finally, the record demonstrates why outcome definitions and results must be read together. It names a primary endpoint and a summary approach, but does not give the numerical result, its uncertainty, or the analyzed population. A completed study status does not substitute for these statistical details. The record's limitations make it important to distinguish what the study set out to measure from what the available results can support.
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.
Several trial-specific limitations constrain interpretation. The registry describes a non-randomized, single-group, open-label study, with no listed comparator arm. This design can document measurements over time but cannot provide a randomized estimate of the difference that would have occurred under another treatment or no treatment. Open-label status also means masking is not listed as a protection against expectations influencing subjective assessments, although the primary measure is PSG total sleep time.
The registry enrollment is 6, but the number contributing to the primary endpoint is not reported. There is no participant flow, no count of complete paired PSG assessments, and no description of missing measurements or their handling. The observed median change and inter-quartile range are also not reported in the registry record. As a result, the endpoint's magnitude, variability, and precision cannot be assessed.
The population description is not fully aligned across the record: the summary names CLL and breast cancer, the condition list names Leukemia and CLL, and the arm description focuses on patients with CLL. The primary outcome population field is blank. The registry record does not establish how participants in these descriptions relate to each other or which group the endpoint would represent.
Only lenalidomide is listed as an intervention, although the study summary refers more broadly to cytotoxic therapy and/or radiation therapy. The record does not report further treatment details, adherence, or treatment exposure. It also does not report the protocol's sample-size justification, statistical analysis plan, multiplicity approach, or analysis population. These omissions prevent a complete assessment of the methods and intended interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Pilot Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy on Cancer Related Sleep Disturbances in CLL and Breast Cancer Patients Experiencing Fatigue — NCT00792077.
- Registry record last updated 2021-07-01; status last verified 2021-06.
- Results first posted 2021-07-01.
- 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
This completed Phase 2 pilot study is registered as open-label, non-randomized, and single-group, with enrollment of 6. The listed intervention is lenalidomide. The primary endpoint is PSG total sleep time in minutes, described as change before and after the first cycle of treatment, up to 8 weeks; the registered summary is median with inter-quartile range.
The registry record does not report the primary outcome result, its uncertainty, or the analysis population. It lists secondary outcomes concerning fatigue, sleepiness, and performance status, but does not report their results. The safety entry records 0 serious adverse events among 6 at risk, 0 other adverse events among 6 at risk, and 0 deaths. Because the study has no listed comparator and the outcome results are not reported in the registry record, its treatment-related sleep-time effect cannot be quantified from that record.