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 Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer (NCT02940223), a randomized phase 2 study. The primary outcome is Cancer Related Fatigue.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02940223 |
| Phase | Phase 2 |
| Condition | Advanced Malignant Neoplasm, Fatigue |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 2 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with advanced malignant neoplasm and fatigue were the intended population. The registry describes advanced cancer as cancer that has spread from its original location to other parts of the body. Enrollment was 2, and the protocol was terminated early because of low accrual. The record does not describe participant characteristics or report how many participants were assigned to each group.
Intervention
Group I was assigned ethyl icosapentate by mouth twice daily for 8 weeks alongside resistance exercises 3 days per week and a walking program at least 5 days per week. The registry also describes an optional period after the initial 8 weeks, but the available description is incomplete.
Comparator
The primary outcome description identifies placebo plus physical activity as the comparison for ethyl icosapentate plus physical activity. Group II was assigned placebo by mouth twice daily for 8 weeks with the same stated resistance and walking schedule. A third group received placebo and stretching exercises; the primary outcome description does not identify that group as part of its stated comparison.
Primary question
The stated question was whether change in cancer-related fatigue from baseline to 57±5 days differed between participants assigned ethyl icosapentate plus physical activity and those assigned placebo plus physical activity. The registry reports that low accrual and early termination meant no analysis was done to determine cancer-related fatigue. Thus, the stated question has no reported result.
3. Trial Design
This was a randomized, double-masked, parallel-group phase II trial sponsored by M.D. Anderson Cancer Center. The registry lists advanced malignant neoplasm and fatigue as conditions. It records enrollment of 2 and a terminated status. The recorded start date is 2017-03-16, and the primary completion date is 2020-11-24. These dates describe the registry record and do not establish when each participant began or finished treatment.
Three groups are named. Group I combined ethyl icosapentate and physical activity; Group II combined placebo and physical activity; Group III combined placebo and stretching exercises. For the first 8 weeks, Groups I and II had the same stated activity schedule: resistance exercises 3 days per week and walking at least 5 days per week. Group III was assigned stretching exercises 3 days per week after meeting with an exercise specialist during the first week. The descriptions include possible activity or treatment after the initial 8 weeks, but those portions are incomplete in the registry record and should not be used to infer the full follow-up protocol.
The primary outcome description focuses on the comparison between Groups I and II, rather than all three groups. Randomization can support a comparison of assigned strategies when outcomes are collected and analyzed as planned, but the registry does not report group sizes, participant-level outcome data, or an analysis. It therefore does not permit assessment of how the randomization operated in practice, whether participants followed their assigned activities, or whether masking was maintained. The statistical analysis plan and any protocol-specific sample-size justification are not reported in the registry 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.
Before assignment: A total of 2 participants were recruited before the study was aborted due to low accrual..
Overall Study
| Stage | Intervention Group (Icosapent Ethyl) | Placebo |
|---|---|---|
| STARTED | 2 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | Intervention Group (Icosapent Ethyl) | Placebo |
|---|---|---|
| Failed Requirement | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Due to low accrual and early termination of the protocol no analysis was done to determine the Cancer related fatigue.
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: A total of 2 participants were recruited before the study was aborted due to low accrual.
| Characteristic | Unit | Intervention Group (Icosapent Ethyl) | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 2 | 0 | 2 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 0 | 2 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Male | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Region of Enrollment: United States | participants | 2 | — | 2 |
| Cancer Type: Colorectal | Participants | 1 | 0 | 1 |
| Cancer Type: Hepatic | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Cancer Related Fatigue, measured over Baseline and at 57±5 days.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was cancer-related fatigue, measured using the 13 questions of the Functional Assessment of Chronic Illness Therapy - Fatigue subscale. The registry describes a four point Likert scale with response anchors from 0, not at all fatigued, to 4, very much fatigued. It defines the outcome as the difference in subscale score between baseline and 57±5 days.
A patient-reported fatigue measure can capture symptoms that may not be represented by laboratory measures alone. Repeating the measure after treatment allows investigators to assess change over time, while comparing change between randomized groups is intended to distinguish the pattern in one assigned strategy from the pattern in its comparator. This is the intended role of the endpoint, not evidence that a difference was observed.
The registry does not report baseline or follow-up scores, a calculated change, an estimate of the between-group contrast, or a confidence interval. It explicitly states that no analysis was done to determine cancer-related fatigue because of low accrual and early termination. Consequently, the endpoint’s observed behavior and the precision of any treatment comparison cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The principal statistical result is the absence of an analyzed primary fatigue outcome. Although the registry defines a comparison between ethyl icosapentate plus physical activity and placebo plus physical activity, it states that no analysis was done to determine cancer-related fatigue. There is therefore no reported estimate of the difference in fatigue change, no confidence interval describing its precision, and no hypothesis-test result to interpret. The data do not establish either a difference or similarity between the assigned strategies.
Enrollment was 2, and the record attributes early termination to low accrual. This very limited enrollment helps explain why the planned outcome could not be analyzed as intended, but the registry does not report group allocation or participant-level data. It is not possible to determine how the two participants were distributed among the three named groups, whether both had fatigue measurements at both time points, or whether any outcome records were available. Those details are not reported in the registry record.
Even if an estimate had been calculated, its interpretation would depend on its magnitude and uncertainty, as well as on the measurement and analysis choices. A confidence interval, in general, expresses the range of effect estimates compatible with the observed data under the method used. With no reported effect estimate or interval, statistical precision cannot be assessed. A lack of a reported test result must not be treated as a finding of no effect: no outcome analysis is different from an analysis that estimates a small effect with uncertainty.
The record also includes adverse-event fields for an intervention group and placebo, with zero values for the listed at-risk and affected counts. Because the recorded at-risk counts are also zero, these entries do not establish that participants experienced no adverse events. The registry information does not provide usable group denominators or an interpretable safety comparison.
In short, the record describes the intended comparison and explains why the primary outcome was not analyzed. It supplies no efficacy estimate, no quantified uncertainty, and no basis for drawing a comparative safety conclusion. The status and enrollment information are essential context for understanding why the result is unavailable, rather than evidence about the direction or size of a treatment effect.
9. Statistical Methods Explained
What comparison was intended?
The primary outcome description defines a comparison of change in fatigue between two assigned strategies: ethyl icosapentate with physical activity and placebo with physical activity. In general, a change-score comparison uses measurements at baseline and follow-up to describe how scores moved over time, then compares those changes between groups. The registry states that the measurement points were baseline and 57±5 days. It does not give a numerical score, a change estimate, or an analysis result.
The registry names a third group receiving placebo and stretching exercises, but the primary outcome description does not include that group in its stated comparison. No further primary-outcome contrast involving the third group is reported. The analysis plan for all three groups is not reported in the registry record.
What does randomization contribute?
In general, random assignment is intended to make treatment groups comparable in expectation with respect to factors measured and unmeasured at the start of a trial. This supports interpreting a between-group outcome contrast as an effect of assignment, provided the design and analysis are carried out appropriately. It does not guarantee that groups will be balanced in a very small trial, and it cannot substitute for having outcome measurements and an analysis.
The record identifies the study as randomized, double-masked, and parallel-group. It does not report the randomization procedure, allocation concealment, group counts, masking assessment, or analysis population. With enrollment of 2 and no primary-outcome analysis, the record does not allow assessment of the practical performance of these design features.
How should uncertainty be understood?
In general, an effect estimate gives a numerical summary of a comparison, while a confidence interval communicates uncertainty around that estimate under specified statistical assumptions. A hypothesis test addresses compatibility between observed data and a null hypothesis under a chosen model; its result does not describe the size or practical importance of an effect by itself. These interpretations require a calculated result. None is reported for the primary fatigue outcome in this record.
Small enrollment generally limits the amount of information available for estimating effects and can make estimates unstable. That is a general statistical consideration, not a calculated finding about this trial’s unreported effect. The record gives no usable primary-outcome estimates from which to assess uncertainty, and no observed-power calculation should be inferred from the enrollment count.
What is not known about the analysis?
The registry does not report a statistical model, an adjustment strategy, assumptions for the primary analysis, handling of repeated measurements, or a method for addressing missing outcome measurements. It also does not report whether an interim analysis was planned or conducted, or how a sample-size target was justified. These omissions mean that the protocol-specific statistical approach cannot be reconstructed from the record.
In general, a prespecified analysis plan helps clarify which comparisons, populations, and outcome definitions will guide interpretation. When the plan is unavailable, readers cannot establish whether a particular analysis was intended or distinguish planned analyses from later choices. Here, the more fundamental limitation is that the registry says the primary fatigue outcome was not analyzed. Explanations of model-based inference therefore describe general concepts only; they do not imply that such a model was fitted for this trial.
Why can activity and treatment assignment complicate interpretation?
In general, a comparison of two treatment groups is easiest to interpret when the groups differ only in the feature being evaluated. The stated primary comparison pairs ethyl icosapentate with physical activity against placebo with physical activity, so the activity component is common to those two assigned strategies. This design description does not show what participants actually received or completed. Adherence, treatment exposure, and activity completion are not reported in the registry record.
The third group used stretching rather than the stated resistance and walking program. Such a group could address a different comparison, but the primary outcome record does not specify an analyzed contrast involving it. Without a reported analysis and group-specific outcomes, no conclusion about the relative contributions of medication, activity, or their combination can be drawn.
10. Multiplicity, Missing Data and Analysis Populations
The registry names one primary outcome, cancer-related fatigue, and two secondary outcomes: Edmonton Symptom Assessment System (ESAS) Score and Hospital Anxiety and Depression Score. It reports three outcome measures in total, but no analyses are listed. The record does not report a multiplicity strategy, such as how interpretation would account for testing more than one outcome or comparison. It also does not give results for the secondary outcomes.
In general, examining multiple outcomes or contrasts can increase the chance of observing an apparently notable result by chance if no plan is used to account for that multiplicity. A prespecified hierarchy or adjustment can help define how evidence should be interpreted. No such plan is reported, and because no outcome analysis is reported, there are no test results to adjust or compare.
Missing-data handling and analysis populations are also not reported in the registry record. It does not say how many participants had baseline or follow-up fatigue measurements, how missing values would be handled, or whether the intended analysis would include all randomized participants or a subset. The enrollment count alone cannot answer those questions. The registry’s statement that no primary analysis was done means that neither a complete-case analysis nor another missing-data approach can be attributed to the study.
These gaps limit reproducibility and interpretation, but they should not be filled by assuming standard practice. The analysis plan, multiplicity procedure, missing-data method, and analysis populations are not reported in the registry record.
11. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized phase II study was designed to examine fatigue in patients with advanced cancer and that it was terminated early because of low accrual. It identifies ethyl icosapentate plus physical activity and placebo plus physical activity as the primary comparison, and it defines fatigue measurement at baseline and 57±5 days. It does not report a primary outcome analysis.
Accordingly, the record does not show whether fatigue improved, worsened, or differed between assigned groups. It does not provide an estimate of the size of a difference or its precision. The absence of an analysis is not evidence that the strategies had identical effects, nor is it evidence that one strategy was better. The stated study question remains unanswered by the posted outcome information.
The record also does not establish how the intervention was experienced or followed, whether participants completed the assigned activity, or whether the planned follow-up measurements were obtained. The optional treatment and activity periods described after the initial 8 weeks are incomplete in the registry record. Those details cannot support conclusions about actual exposure or outcomes.
The adverse-event entries cannot support a safety conclusion: the recorded at-risk counts are zero, as are the affected counts. Without interpretable participant denominators and event information, zero entries should not be read as demonstrating an absence of adverse events.
More generally, trial design and outcome definitions describe what investigators intended to learn; analyzed results are needed to quantify what the observed data indicate. In this case, the record provides design information but no numerical primary result. Any claim about efficacy, equivalence, benefit, or harm would go beyond the evidence recorded.
12. Why This Trial Matters Statistically
This trial illustrates an important distinction between a registered research question and an answer supported by analyzed data. The record describes randomization, masking, parallel groups, a defined fatigue measure, and a stated comparison. Those details clarify the intended design, but they cannot replace outcome results. Because the primary fatigue outcome was not analyzed, the central comparison cannot be quantified.
Low accrual and early termination are statistically consequential because limited enrollment restricts the information available for estimating group differences. This is a general point about precision, not a claim about an unreported effect in this trial. In this record, the immediate consequence is that no primary outcome estimate or uncertainty measure is available at all.
The trial also shows why registry interpretation requires attention to denominators and analysis status. The adverse-event fields contain zero counts, but the recorded at-risk counts are zero too. Those values do not provide a meaningful basis for judging event frequency. Similarly, an enrollment count does not reveal group allocation, measurement completeness, or the analysis population.
For clinical researchers and biostatisticians, the record is a reminder that clear reporting should distinguish planned outcomes from analyzed outcomes and should make group counts, outcome availability, analytic methods, and uncertainty interpretable. When those elements are absent, the correct statistical conclusion is limited: the comparison was intended, but its result is not reported. That distinction prevents missing evidence from being mistaken for evidence of no difference.
13. 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 dominant limitation is the absence of an analysis of the primary fatigue outcome. The registry explicitly attributes this to low accrual and early termination. Enrollment was 2, and the record does not provide group allocation or participant-level outcomes. As a result, no estimate or uncertainty measure can be evaluated.
The trial included three named groups, while the primary outcome description identifies a comparison involving two of them. The record does not report an analyzed comparison involving the placebo and stretching group. The optional post-8-week descriptions are incomplete, so the full intended treatment and activity schedule cannot be established from the available record.
Participant characteristics, baseline fatigue scores, follow-up scores, adherence, withdrawals, and missing outcome measurements are not reported. The statistical analysis plan, sample-size justification, interim analyses, multiplicity strategy, and missing-data approach are also not reported in the registry record. Their absence prevents assessment of whether the planned methods were suitable or how an analysis would have handled incomplete data.
The adverse-event entries list zero participants at risk as well as zero affected participants. Without interpretable denominators or event details, those entries cannot be treated as evidence of safety. Overall, the registry supports description of the study’s intent and early termination, but not an efficacy or safety comparison.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer — NCT02940223.
- Registry record last updated 2021-06-10; status last verified 2021-05.
- Results first posted 2021-06-10.
- 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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17. Record Summary
The registry record describes a randomized, double-masked, parallel-group phase II trial sponsored by M.D. Anderson Cancer Center. It was intended to study fatigue in patients with advanced cancer. The record lists enrollment of 2, a start date of 2017-03-16, a primary completion date of 2020-11-24, and terminated status.
Three groups are named: ethyl icosapentate with physical activity, placebo with physical activity, and placebo with stretching exercises. The primary outcome was change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale score from baseline to 57±5 days. The stated primary comparison was between ethyl icosapentate plus physical activity and placebo plus physical activity.
Because of low accrual and early termination, no analysis was done to determine the primary fatigue outcome. The registry also lists ESAS Score and Hospital Anxiety and Depression Score as secondary outcomes, but reports no analyses. It does not provide an interpretable comparative efficacy or safety result.