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 Levocarnitine in Treating Fatigue in Cancer Patients (NCT00091169), a randomized phase 3 study. The primary outcome is Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00091169 |
| Phase | Phase 3 |
| Condition | Fatigue, Unspecified Adult Solid Tumor, Protocol Specific |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 376 |
| Arms in the primary outcome | 2 |
| Lead sponsor | ECOG-ACRIN Cancer Research Group |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned patients with fatigue and an unspecified adult solid tumor, protocol specific. The primary outcome description identifies the analysis population as all randomized patients. The registry does not report further eligibility details in this record.
Intervention
Patients assigned to levocarnitine received it orally twice daily during weeks 1-4. The registry identifies levocarnitine as a dietary supplement.
Comparator
The comparison group received oral placebo twice daily during weeks 1-4. The trial was randomized and triple-masked, although the registry record does not specify which parties were masked.
Primary question
The primary question was whether the mean change in Brief Fatigue Inventory score from baseline to 4 weeks differed between the levocarnitine and placebo groups. The scale runs from 0-10, with higher scores representing worse fatigue.
This was a phase III trial sponsored by ECOG-ACRIN Cancer Research Group. The registry describes its purpose as comparing levocarnitine with placebo for treating fatigue in patients with cancer. The primary outcome was change in fatigue score, calculated as the score at 4 weeks minus the score at baseline. A negative change therefore represents a lower fatigue score at the later assessment; because higher scores represent worse fatigue, that direction is a reduction in the measured score.
The central statistical issue is how the two groups' observed changes compare, and how much uncertainty surrounds that comparison. The registry reports group means with confidence intervals and a Wilcoxon (Mann-Whitney) comparison with a p-value. It does not report a between-group estimate with a confidence interval for the primary comparison. Consequently, the group summaries and the reported test answer related but not identical questions: the summaries describe each arm, while the test assesses the between-group comparison using its stated method.
The clinical question is narrower than whether fatigue changes over time in either group. Both groups were assessed at baseline and 4 weeks, and the relevant contrast is between randomized groups over that interval. The record does not report longer-term fatigue outcomes for the primary endpoint or additional details about the population beyond the conditions and primary analysis population listed in the registry.
3. Trial Design
This completed phase III trial used randomized allocation, triple masking, and a parallel-group model. The registry reports enrollment of 376. The primary outcome was assessed at baseline and 4 weeks after randomization. Levocarnitine and placebo were both given orally twice daily during weeks 1-4. These design features establish the intended comparison over the treatment period, but the registry record does not describe the randomization procedure, allocation concealment, or the identities of the parties included in triple masking.
The primary analysis population is described as all randomized patients. The arm summaries for the primary endpoint list 189.0 for levocarnitine and 187.0 for placebo. These are the endpoint summaries recorded in the registry; the record does not explain whether all randomized patients had outcome data available or how missing measurements were handled. The listed arm values should not be treated as evidence of a particular missing-data procedure.
The trial began on 2005-12-16, and primary completion is recorded as 2008-03. Its status is completed. The record lists fatigue and unspecified adult solid tumor, protocol specific, as conditions. It does not provide further enrollment criteria, the clinical setting, or details of the disease characteristics of enrolled participants.
Several secondary outcomes are listed, including fatigue measured with FACIT-F, depression measured with CES-D, pain measured with the Brief Pain Inventory, carnitine deficiency, and performance status. The registry reports six outcome measures and six analyses overall, while the detailed secondary outcome data available in this record include the stable-or-improving performance-status measure. The record does not report whether secondary outcomes were prespecified in a statistical analysis plan, or how their analyses were organized beyond the methods named alongside the outcomes.
Randomization and masking can reduce some forms of bias in a treatment comparison, but they do not by themselves resolve questions about missing outcome data, analysis choices, or the precision of estimates. The registry record does not report a sample-size justification, a detailed statistical plan, or interim analyses. Those omissions limit what can be concluded about the trial's planning and analysis process from this record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Levocarnitine | Placebo |
|---|---|---|
| STARTED | 189 | 187 |
| Treated | 163 | 170 |
| COMPLETED | 132 | 134 |
| NOT COMPLETED | 57 | 53 |
Reasons for not completing this period:
| Reason | Levocarnitine | Placebo |
|---|---|---|
| Disease progression | 3 | 1 |
| Adverse Event | 11 | 17 |
| Death | 4 | 1 |
| Withdrawal by Subject | 10 | 13 |
| Other | 3 | 4 |
| Not start protocol therapy | 26 | 17 |
Analysis population for the primary outcome, as defined in the registry: All randomized patients
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.
Population: All randomized patients
| Characteristic | Unit | Levocarnitine | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 189 | 187 | 376 | |
| Age, Continuous | years | 64 (29 to 91) | 62 (30 to 88) | 63 (29 to 91) |
| Sex: Female, Male: Female | Participants | 111 | 79 | 190 |
| Sex: Female, Male: Male | Participants | 78 | 108 | 186 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks, measured over assessed at baseline and 4 weeks after randomization.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the mean change in fatigue measured with the Brief Fatigue Inventory (BFI) from baseline to 4 weeks. The BFI summary is the average of its nine items, on a scale ranging from 0-10. Higher averages indicate worse fatigue. The reported change is the BFI score at 4 weeks minus the score at baseline, so a negative value indicates a lower average score at follow-up than at baseline.
A continuous score retains more information about the measured level of fatigue than a simple classification such as improved or not improved. Comparing average changes can describe how the groups' scores shifted over the assessment interval. The mean is a familiar summary, but a mean alone does not show the full distribution of individual changes, and it can be affected by unusual values. The registry's reported primary comparison uses a Wilcoxon (Mann-Whitney) test rather than reporting a mean difference between groups.
The endpoint is useful for focusing the trial on a defined, patient-reported measure over a specified interval. It does not, by itself, describe every aspect of fatigue, explain why a score changed, or establish whether an individual participant experienced a meaningful change. The registry record does not report a threshold for a clinically important change, additional interpretation guidance for the BFI, or the detailed procedure used to collect and process the questionnaires.
Each arm's mean change is reported with a 95% confidence interval. Those intervals describe uncertainty around the arm-specific means; they are not a confidence interval for the difference between arms. The record does not provide a confidence interval for the primary between-group effect, so the precision of that particular contrast cannot be read directly from an interval reported for either arm alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The mean BFI change was -0.96 in the levocarnitine arm, with a 95% confidence interval from -1.32 to -0.6. In the placebo arm, the mean change was -1.11, with a 95% confidence interval from -1.44 to -0.78. Since lower BFI scores represent less fatigue, both arm means describe a decrease in the measured score over the assessment interval. The placebo arm's mean change is numerically more negative, but that observation alone does not establish a treatment difference.
The registry reports a Wilcoxon (Mann-Whitney) comparison with p = 0.57. This is the recorded inferential comparison for the primary outcome. A p-value is not the probability that either treatment is effective, nor does it measure the size or clinical importance of a difference. It describes how compatible the observed data are with the null hypothesis under the test's assumptions. The record does not report the test statistic, an effect estimate for the comparison, or a confidence interval for that estimate.
It is therefore important not to interpret the two arm-specific confidence intervals as if they directly measured the uncertainty in the difference between arms. Overlap or non-overlap of separate intervals is not a substitute for a confidence interval or test of the between-group contrast. The reported p-value addresses the comparison, but without a corresponding effect estimate and interval, the registry record gives less direct information about the magnitude and precision of that contrast.
General statistical interpretation: a result that does not provide strong evidence against a null hypothesis is not the same as evidence that two treatments are equivalent. Establishing equivalence or non-inferiority usually requires a prespecified margin and an analysis designed for that question. Such a margin and analysis are not reported in the registry record. The primary p-value should therefore be read as the result of the reported comparison, not as proof of equality or as a definitive statement about the size of any possible difference.
The endpoint is measured from baseline to 4 weeks, so the reported result speaks to that assessment interval. It does not establish what happened at later times. The registry identifies all randomized patients as the primary population, but does not describe the handling of missing measurements or provide additional details on the analysis population behind the recorded arm summaries. Those details matter when judging how completely the reported estimates represent the randomized groups.
Overall, the posted primary results show negative mean changes in both arms and a reported between-group p-value of 0.57. The data should be read as a comparison of the recorded BFI outcomes over the specified interval, with uncertainty about the between-group effect not fully characterized by a reported effect confidence interval. They do not, on their own, establish equivalence, explain individual experiences, or answer questions about outcomes beyond the registry's stated assessment time.
9. Statistical Methods Explained
What does a mean change summarize? The primary outcome is a continuous measure, and the registry reports the mean change in each arm. A change score is formed by subtracting the baseline score from the follow-up score. Here, the specified convention is follow-up minus baseline, so negative values indicate a lower follow-up score. Because higher BFI averages represent worse fatigue, a negative change points toward a lower measured fatigue score over the interval. This group-level description does not mean every participant's score changed in the same direction.
A mean gives a single summary of the average change, but it does not show how spread out individual changes are or whether the distribution is skewed. A continuous outcome can be summarized in multiple ways, and the most suitable comparison depends on the estimand and analysis plan. The registry lists a mean and confidence interval for each arm but names a Wilcoxon (Mann-Whitney) test for the primary comparison. The record does not explain the rationale for choosing that test or specify an effect measure aligned with it.
What does a confidence interval tell the reader? General statistical explanation: a confidence interval expresses uncertainty around an estimate under the assumptions of the method used to construct it. A narrower interval indicates greater precision for that estimate; a wider interval indicates less precision. The reported 95% confidence intervals apply to the separate arm means. They do not give the interval for the difference between the arms. A direct interval for the treatment contrast would show which values of that contrast are compatible with the data and method, but such an interval is not reported for the primary endpoint.
Why use a rank-based comparison? The Wilcoxon (Mann-Whitney) test is a rank-based method for comparing observations from two groups. General statistical explanation: rather than relying directly on a comparison of means under a normal-distribution model, rank-based testing uses the ordering of observed values. Its interpretation depends on the distributions and the question being tested; it should not automatically be described as a test of means. The registry gives the method name and p-value but does not report the exact test statistic, any distributional assessment, or a detailed account of how ties or missing observations were handled.
A p-value measures compatibility between the observed data and a null model, conditional on the test and its assumptions. It is not a measure of the probability that the null hypothesis is true, and it does not indicate the size of an effect. The primary p-value is recorded as 0.57. Without a between-group effect estimate and confidence interval, readers have less direct information about the range of plausible treatment contrasts than they would with both an estimate and its uncertainty interval.
Why can over-dispersion matter? General statistical explanation: over-dispersion occurs when observed variability is greater than a model assumes. If a model underestimates variability, its standard errors can be too small and its confidence intervals too narrow, which can make evidence appear more precise than it is. This is a general consideration for statistical modeling, not a reported feature of this trial. The registry record does not describe an over-dispersion assessment or identify a model for the primary continuous outcome; it reports a rank-based test.
How should planning illustrations be read? The record's sample-size assumptions describe a planning illustration based on the observed effect, with two-sided significance level 0.05, equal allocation between arms, and a normal approximation. The illustration considers detecting stated fractions of the observed effect and expresses planning needs as participants per arm for 80% power and participants per arm for 90% power. It is not the trial's original design calculation, and it is not observed power. The registry record does not report the trial's own sample-size justification, the effect size assumed during original planning, or the statistical plan used to determine enrollment.
General statistical explanation: sample-size calculations depend on assumptions about the effect to detect, variability, allocation, significance level, and analysis method. A planning result based on an observed effect is especially dependent on the observed estimate, which may be imprecise. It should be treated as an illustration of what a future design might require under stated assumptions, not as evidence about how adequately this completed trial was planned or as a measure of the probability that its result is correct.
What can be learned from the secondary comparison? For the listed performance-status outcome, the registry reports a Fisher Exact analysis and also records an unadjusted recalculation. General statistical explanation: an unadjusted p-value addresses one comparison without accounting for the number of other outcomes or tests examined. If many tests are considered, the chance of obtaining at least one apparently noteworthy result by chance can increase. The registry record does not report a multiplicity adjustment or a prespecified hierarchy for interpreting secondary outcomes, so those results warrant more caution than a single, clearly designated primary analysis.
The reported confidence intervals and p-values describe sampling uncertainty under their respective methods. They do not account for every possible source of bias, such as missing data, measurement issues, or selective reporting. Those issues require information about study conduct and analysis choices, several of which are not reported in the registry record. Statistical results are most informative when estimates, uncertainty intervals, analysis populations, and methods are considered together.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Wilcoxon (Mann-Whitney) | not reported | 0.570 |
The registry records a Wilcoxon (Mann-Whitney) analysis for the primary comparison, with p = 0.57. It also reports the arm-specific mean changes and their 95% confidence intervals. No recalculated primary between-group estimate or confidence interval is listed in the record, so there is no recalculated primary contrast to set beside the recorded test result. The arm-specific means should not be mistaken for a directly reported difference between arms.
For performance status, the registry records a Fisher Exact analysis and an unadjusted recalculation. The posted comparison details should be read as distinct analyses, with the registry-reported method and recalculated summary retaining their stated meanings. A recalculation based on posted summary data is not a replacement for the trial's full analysis, which may depend on participant-level data and analysis choices not described in the registry record. The record marks no discrepancy. It does not give enough detail to explain all analytical decisions or reconcile estimates beyond the information recorded.
More generally, a recalculated result is a simple, unadjusted calculation from the posted summaries, not a reconstruction of the original analysis plan. When a recalculation and the trial's own analysis conflict, the trial's own analysis takes precedence. The primary outcome does not include a recalculated comparison in this record, so interpretation should center on the recorded Wilcoxon result and the limits of the arm-level summaries.
11. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is identifiable, but the registry record does not report a complete statistical analysis plan. In particular, it does not specify a multiplicity adjustment, a testing hierarchy for secondary outcomes, or how the family of analyses was intended to be interpreted. This matters because the record lists multiple secondary outcomes and six outcome measures overall. When several hypotheses are tested, an unadjusted analysis does not control the chance of a false-positive result across the full set of tests. Without a stated strategy, secondary p-values should not be treated as though they carry the same evidential weight as an isolated primary test.
The primary outcome description names all randomized patients as the population of interest. That is useful, but the registry record does not explain how the analysis handled randomized patients without a recorded 4-week BFI score. It does not report the amount or pattern of missing outcome data, imputation methods, sensitivity analyses, or whether the analysis followed an intention-to-treat approach in a specified operational sense. The listed arm summaries alone do not establish how missingness was addressed.
For performance status, the endpoint-specific denominators are 155.0 for Arm I and 160.0 for Arm II. The record does not explain why those denominators differ from the primary arm summaries, or whether exclusions, unavailable assessments, or another reason account for the difference. The registry also does not describe missing-data handling for the other secondary outcomes. No reason should be assigned to these differences without further information.
The registry record does not report interim analyses, stopping rules, or a sample-size justification for the original trial. It does include assumptions for a planning illustration, but those assumptions are not a substitute for the original design rationale. The record also does not report whether outcome definitions or analysis methods changed during the trial. These omissions do not prove that a particular issue occurred; they mean the relevant procedures cannot be assessed from this registry record alone.
General statistical explanation: missingness can affect both precision and validity, particularly if the chance of an outcome being observed is related to the outcome itself or to group assignment. Multiplicity can affect the interpretation of a collection of results even when each individual analysis is correctly calculated. These are separate concerns: a multiplicity procedure does not solve missing-data problems, and a missing-data method does not control for multiple testing. Both require methods and assumptions that are not reported in the registry record.
12. 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 |
|---|---|---|---|
| Levocarnitine | 8 | 166 | 4.8% |
| Placebo | 8 | 171 | 4.7% |
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 |
|---|---|
| Levocarnitine | 10 of 166 |
| Placebo | 9 of 171 |
Most frequent serious adverse event terms
| Event term | Organ system | Levocarnitine | Placebo |
|---|---|---|---|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | 1 of 166 | 3 of 171 |
| Nausea | Gastrointestinal disorders | 2 of 166 | 2 of 171 |
| Death - disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 166 | 2 of 171 |
| Fatigue | General disorders | 2 of 166 | 0 of 171 |
| Vomiting | Gastrointestinal disorders | 1 of 166 | 1 of 171 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 2 of 166 | 0 of 171 |
| Anemia | Blood and lymphatic system disorders | 0 of 166 | 1 of 171 |
| Platelets decreased | Investigations | 0 of 166 | 1 of 171 |
| Atrial fibrillation | Cardiac disorders | 0 of 166 | 1 of 171 |
| Pruritus/itching | Skin and subcutaneous tissue disorders | 1 of 166 | 0 of 171 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Levocarnitine | Placebo |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 10 of 166 | 9 of 171 |
Serious events with the highest arm-level rate: diarrhea w/o prior colostomy (1.8%), fatigue (1.2%), nausea (1.2%), dyspnea (1.2%), death - disease progression nos (1.2%).
The registry reports serious adverse events among participants at risk of 166 in the levocarnitine group and 171 in the placebo group. Serious adverse events affected 8 in each group. Other adverse events affected 10 in the levocarnitine group and 9 in the placebo group. These are registry counts for the stated risk groups, not a complete description of event timing, severity beyond the serious classification, or each participant's clinical course.
The registry also lists serious adverse event terms and percentages, including diarrhea w/o prior colostomy at 1.8%, fatigue at 1.2%, nausea at 1.2%, dyspnea at 1.2%, death - disease progression NOS at 1.2%, and pruritus/itching at 0.6%. The record does not provide an arm-specific breakdown for each listed term in the information recorded. The listed term concerning death is an adverse-event term; the registry does not report a group-level death count in the adverse-event summary.
General statistical explanation: safety counts are descriptive and depend on how events were defined, collected, and attributed. Small differences in counts do not by themselves establish a causal treatment effect, and the counts do not show the uncertainty around a comparative risk. The registry record does not report detailed event narratives, exposure-adjusted rates, or a formal between-group safety analysis. The figures should therefore be read as reported event summaries rather than as a complete comparative assessment of safety.
13. What the Result Does, and Does Not, Mean
The primary results describe changes in a specific fatigue measure over a defined period. Both arm means moved in the direction of lower BFI scores, and the registry reports a Wilcoxon (Mann-Whitney) comparison with p = 0.57. Taken together, these are the posted results for the primary endpoint. They do not establish that the treatments are equivalent, and the reported p-value does not quantify the size of a possible difference.
The registry reports confidence intervals for each arm's mean change, but not for the primary between-group contrast. A reader can assess the reported arm-level uncertainty, but cannot use those intervals as a direct substitute for the uncertainty around the difference between treatments. The lack of a reported contrast interval limits how precisely the possible comparative effect can be described from this record.
The result applies to the BFI average, as defined in the registry, and to the baseline-to-4-week assessment. It does not establish whether scores remained different or changed later, and it does not describe other dimensions of fatigue or every participant's experience. The record lists other outcomes, but numerical information for most of them is not reported in the registry record.
General statistical explanation: a non-significant result, considered on its own, does not prove that there is no effect. The data may be compatible with a range of effects, and the breadth of that range is best assessed using a confidence interval for the comparative estimate. Because the primary comparison interval is not reported, claims about what differences are ruled out would go beyond the information recorded.
The trial's randomized and triple-masked design is relevant context for interpreting the comparison, but the registry record does not specify details such as the randomization procedure or who was masked. It also does not describe missing-data handling, multiplicity control, or the original sample-size rationale. These omissions affect the scope of conclusions that can be drawn from registry results, without demonstrating that a particular source of bias occurred.
Accordingly, the posted data support a restrained description: the registry reports arm-level mean changes and a primary comparison test over 4 weeks, but does not provide a confidence interval for the primary between-group effect. The results do not establish equivalence, a benefit, or a lack of benefit, and they do not answer questions outside the measured outcomes and timeframe.
14. Why This Trial Matters Statistically
This trial illustrates why reporting an outcome estimate and its uncertainty for each arm is not the same as reporting the comparative effect that a randomized trial is designed to estimate. The BFI means describe average change within each group, while the Wilcoxon (Mann-Whitney) p-value addresses the primary comparison. Without a between-group effect estimate and confidence interval, readers have a less direct account of the magnitude and precision of the contrast.
It also demonstrates the importance of matching an analysis to its interpretation. A rank-based test and a comparison of means are not automatically interchangeable. The registry reports both arm means and a rank-based test, but does not explain the rationale or provide an effect measure that directly accompanies the test. Clear reporting of the estimand, method, estimate, and interval helps readers understand what was compared and what conclusions are supported.
The secondary outcomes raise a separate lesson about multiplicity. Trials can collect several clinically relevant measures, but each additional analysis adds another result to interpret. Without a reported testing hierarchy or adjustment plan, an unadjusted secondary result carries more uncertainty as part of a larger set of comparisons. Incomplete numerical reporting for the listed secondary outcomes also limits assessment of whether those measures align with the primary finding.
Finally, the registry record separates observed results from planning assumptions only partly: it includes a sample-size planning illustration based on the observed effect, while the original sample-size justification is not reported. Such an illustration can inform future planning under its assumptions, but it cannot show the original design's adequacy or be interpreted as observed power. The distinction is important whenever planning calculations are presented alongside completed-trial results.
These features make the record useful for teaching careful interpretation: retain the endpoint definition, distinguish arm summaries from between-group evidence, read p-values as conditional statistical measures, and account for missing information before making broad claims. The most informative conclusion is bounded by what was measured and what the registry actually reports.
15. 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 limitations are specific to the information recorded for this trial. The primary analysis is identified as involving all randomized patients, but the record does not explain how many had usable BFI measurements at the 4-week assessment or how missing values were handled. The primary arm summaries list endpoint-specific values, but those entries do not establish whether all randomized patients contributed to the mean or to the Wilcoxon test.
The primary comparison is reported through a p-value, without a between-group effect estimate and confidence interval. This makes it difficult to assess the size and precision of the comparative result directly. The arm-specific confidence intervals are informative about the separate means but do not answer that same question. The record also does not report the test statistic or details needed to fully assess the rank-based analysis.
The secondary outcome information is incomplete in this record. Five secondary outcomes are listed, but numerical results are reported in detail for performance status. The record does not report a multiplicity strategy, so any unadjusted secondary findings must be interpreted cautiously. The performance-status analysis also has outcome-specific denominators, and the reasons for those denominators are not reported.
Although the design is described as randomized, triple-masked, and parallel-group, the registry record does not provide details about the randomization procedure, allocation concealment, or which parties were masked. It does not report the original sample-size justification, an interim-analysis plan, or a complete statistical analysis plan. These are reporting limitations in the registry record and should not be mistaken for evidence that the trial did or did not follow procedures that are not described.
The primary assessment covers baseline to 4 weeks, and the record does not provide longer-term primary outcome results. Safety summaries include counts and selected serious adverse-event terms, but do not provide event-level detail or a formal comparative safety estimate. These constraints limit the range of questions that can be answered using this registry record alone.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Levocarnitine in Treating Fatigue in Cancer Patients — NCT00091169.
- Registry record last updated 2023-07-05; status last verified 2023-06.
- Results first posted 2016-05-30.
- 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.
Continue through the Clinical Biostats statistical pathway
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19. Record Summary
NCT00091169 is a completed phase III randomized, triple-masked, parallel-group trial sponsored by ECOG-ACRIN Cancer Research Group. Enrollment is recorded as 376. The trial compared oral levocarnitine with oral placebo, both given twice daily during weeks 1-4, in patients with fatigue and an unspecified adult solid tumor, protocol specific.
The primary outcome was mean change in BFI score from baseline to 4 weeks, with higher scores indicating worse fatigue. The registry reports negative mean changes in both arms and a Wilcoxon (Mann-Whitney) comparison with p = 0.57. It does not report a confidence interval for the primary between-group effect. Secondary outcomes are listed, with detailed numerical results recorded for performance status; safety counts and selected serious-event terms are also reported.
The trial began on 2005-12-16, primary completion is recorded as 2008-03, and the status is completed. Missing-data methods, multiplicity handling, and the original sample-size justification are not reported in the registry record.