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 Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer (NCT05911243), a randomized na study. The primary outcome is Accrual (Feasibility).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05911243 |
| Phase | NA |
| Condition | Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage II Gastric Cancer AJCC v8 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 3 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
People with stage II-IV gastric, esophageal, or pancreatic cancer. The listed conditions include gastric cancer, esophageal adenocarcinoma and squamous cell carcinoma, and pancreatic cancer.
Intervention
Auricular acupressure added to usual care. The intervention description refers to pellets attached to specific locations on the external ear. Participants in this arm were also to have blood samples collected during the study.
Comparator
Usual care, with blood samples also collected during the study. The registry record does not describe usual care in further detail.
Primary question
Could the study enroll participants at the planned rate? Accrual was defined as the average number of participants enrolled per month into both groups, with a goal of 5 patients/month over a 15-month period.
The study was designed to assess feasibility and acceptability, not simply to compare appetite or weight outcomes. Its stated rationale concerns appetite loss and weight loss associated with cancer. The registry record lists changes in appetite and body weight as secondary outcomes, but the available results do not include outcome estimates or a comparison between groups.
Although the study was randomized, the posted allocation counts are highly imbalanced: all 3 randomized participants were assigned to usual care, and none were assigned to auricular acupressure. Consequently, the posted results cannot support an estimate of the difference between the intervention and comparator arms. The record does not report why all participants were allocated to usual care or why the study was terminated.
3. Trial Design
The registry describes a randomized, double-masked, parallel-group study. The sponsor was the University of Washington. The study title identifies it as a pilot and feasibility study of an acupressure intervention for appetite and weight in people with gastric, esophageal, or pancreatic cancer.
The intervention arm was assigned auricular acupressure in addition to usual care. The comparator arm received usual care. Both arms were also described as having blood samples collected during the study. Questionnaire administration is listed among the interventions, but the registry record does not give further details about which questionnaires were used or when they were administered. The people or procedures covered by double masking are not reported in the registry record.
The listed eligibility conditions cover stage II-IV gastric cancer, esophageal adenocarcinoma or squamous cell carcinoma, and pancreatic cancer. Further eligibility criteria are not reported in the registry record. The phase is listed as not applicable.
The study started on 2024-07-22, and its primary completion date is listed as 2025-07-09. Its status is terminated. The registry record does not report the reason for termination. Enrollment is listed as 3 participants. The posted arm counts show 0 in the auricular acupressure arm and 3 in the usual-care arm; the record states that all randomized participants were allocated to usual care.
These design features are important when interpreting the results. Randomization describes the intended study design, but it does not create an intervention-versus-comparator estimate when no participants are listed in one arm. The available results therefore describe the enrollment and allocation recorded, rather than a randomized comparison of clinical outcomes.
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 | Arm I (Acupressure Therapy) | Arm II (Usual Care) |
|---|---|---|
| STARTED | 0 | 3 |
| COMPLETED | 0 | 1 |
| NOT COMPLETED | 0 | 2 |
Reasons for not completing this period:
| Reason | Arm I (Acupressure Therapy) | Arm II (Usual Care) |
|---|---|---|
| Lost to Follow-up | 0 | 1 |
| Death | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants were allocated to Arm II (usual care).
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: Three participants were randomized into Arm II (usual care). No participants were randomized into Arm I (acupressure therapy).
| Characteristic | Unit | Arm I (Acupressure Therapy) | Arm II (Usual Care) | Total |
|---|---|---|---|---|
| Participants analysed | 0 | 3 | 3 | |
| Age, Categorical: <=18 years | Participants | — | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | — | 3 | 3 |
| Age, Categorical: >=65 years | Participants | — | 0 | 0 |
| Age, Continuous | years | — | 54 (45 to 62) | 54 (45 to 62) |
| Sex: Female, Male: Female | Participants | — | 1 | 1 |
| Sex: Female, Male: Male | Participants | — | 2 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | — | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | — | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | — | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | — | 0 | 0 |
| Race (NIH/OMB): White | Participants | — | 3 | 3 |
| Race (NIH/OMB): More than one race | Participants | — | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | — | 0 | 0 |
| Region of Enrollment: United States | participants | — | 3 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Accrual (Feasibility), measured over Up to 2 years, during study accrual.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is accrual, measured as a count of participants and described in terms of the average number enrolled per month across both groups. The registry record sets a goal of 5 patients/month over a 15-month period. Accrual is a feasibility outcome: it asks whether recruitment proceeds at a rate that can support the conduct of the study. It is not a measure of appetite, body weight, treatment effect, or safety.
The posted primary result lists 3 participants in total: 0 in the auricular acupressure arm and 3 in the usual-care arm. The average monthly accrual rate is not reported in the registry record. Although the record gives a study start date and a primary completion date, those dates alone do not establish the period over which accrual occurred or permit a reliable estimate of the specified rate.
Accrual is useful in a feasibility study because recruitment can determine whether a larger or longer study is practical. It should be interpreted alongside other feasibility information, such as participant acceptability and the ability to deliver the intervention. Such results are not reported in the registry record. The enrollment count therefore gives limited information about recruitment, but it does not explain why enrollment ended at 3 or why all randomized participants were assigned to usual care.
The listed secondary outcomes include change in appetite and change in body weight. No estimates for those outcomes are posted. The primary endpoint should not be read as evidence about whether acupressure changes appetite or weight.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The principal result is an enrollment count of 3 participants, with all 3 assigned to usual care and none assigned to auricular acupressure. The registry record lists a recruitment goal of 5 patients/month over a 15-month period, but it does not post an average monthly accrual rate. Thus, the available result does not give a direct rate-based assessment against that goal.
The allocation pattern has a decisive consequence for comparative interpretation. A treatment contrast requires outcome information from both arms. With no participants listed in the acupressure arm, the posted results cannot estimate an arm difference for appetite, body weight, or other outcomes. The registry lists changes in appetite and body weight as secondary outcomes, but does not report their results. There are no posted analyses, and the record does not report confidence intervals, hypothesis tests, or adjusted effect estimates.
The absence of an estimate is not evidence that the groups had the same outcomes, nor does it show that the intervention has no effect. It means the registry record does not contain the information needed to make those comparisons. Likewise, the enrollment count alone does not establish why recruitment stopped or whether participants found the intervention acceptable. The reason for termination and acceptability results are not reported in the registry record.
Precision is also a concern even for descriptive findings. Counts from a very small enrolled group provide little information about how recruitment or safety might look in a larger group or another setting. No uncertainty interval for the accrual rate is posted, and the rate itself is not reported. No assumptions should be made about recruitment outside the study or about participants who may have been screened but not enrolled.
The safety entries list no serious adverse events and no other adverse events among the 3 participants at risk in usual care, and one death in that group. There were no participants at risk in the acupressure arm. These counts do not permit an arm-to-arm safety comparison, and the registry does not report a cause or attribution for the death. The counts describe what is posted, not whether an event was related to study participation.
Overall, the posted results document a terminated study with 3 participants and an allocation entirely to usual care. They do not provide an intervention efficacy estimate, an accrual rate, or a comparative safety assessment. The missing analyses and outcomes should not be replaced by conclusions based on the study title, rationale, or planned objectives.
9. Statistical Methods Explained
What does a feasibility endpoint measure?
Feasibility endpoints address whether a study can be carried out as intended. Accrual is one such measure: it describes how quickly participants enter a study. In this registry record, accrual is defined using an average monthly enrollment rate across both groups, with a goal of 5 patients/month over a 15-month period. This planned benchmark is distinct from an observed result. The posted count is 3 participants, but an average monthly rate is not reported in the registry record.
In general, recruitment benchmarks help researchers judge whether a future study may be practicable. They do not establish that a treatment changes a health outcome. Feasibility is usually considered alongside other questions, such as whether participants accept the study procedures and whether the intervention can be delivered as planned. The registry record does not report results for those questions.
Why is a treatment comparison unavailable?
In a parallel-group randomized study, participants are assigned to one of the study arms, and outcomes can be compared between the groups when results are available for both. Here, the posted counts are 0 in the auricular acupressure arm and 3 in usual care. The record also states that all randomized participants were allocated to usual care. With no participants in the intervention arm, there is no posted two-arm outcome contrast to estimate.
Randomization is a design feature intended to support a fair comparison by assigning participants according to a chance-based process. It cannot by itself provide comparative evidence when the posted results contain no participants in one arm and no corresponding outcomes. The record does not explain the allocation pattern, so its cause should not be inferred.
What would an estimate and confidence interval convey?
In general, an effect estimate summarizes the observed contrast between groups, while a confidence interval describes the uncertainty around that estimate under the statistical model used. A narrow interval indicates greater precision than a wide one, though interpretation also depends on the outcome and study design. No arm comparison or confidence interval is reported in the registry record. With the posted arm counts, a comparison based on participant outcomes is not available.
A p-value, when reported, is a measure of how compatible data are with a specified statistical model and null hypothesis. It is not a measure of the size or importance of an effect. No p-values or hypothesis tests are posted for this study. Their absence should not be interpreted as a result in favor of either group.
How should planning illustrations be understood?
In general, sample-size planning asks how many participants a future study might need under stated assumptions about the effect to detect, variability, significance level, allocation, and statistical method. A planning illustration based on an observed effect is not the same as a prospective design justification. It also cannot establish what a study with a larger sample would find.
The registry record does not report the study's own sample-size justification. Any sample-size illustration should be treated as planning information rather than as observed power. Observed power is not a substitute for interpreting an effect estimate and its uncertainty. In this study, no two-arm effect estimate is posted from which to draw a comparative conclusion.
What does the statistical record contain?
The primary endpoint is a participant count tied to an accrual-rate goal. The record lists 9 outcome measures and 4 posted secondary outcome entries, including change in appetite and change in body weight. No statistical analyses are posted. The secondary outcome entries do not include results that would allow a reader to assess change or compare groups. The record does not report an analysis model, covariate adjustment, confidence intervals, or a method for handling repeated measurements.
Some outcomes, such as counts, may be summarized descriptively. In general, counts are most informative when their denominators and the way events were collected are clear. The serious and other adverse event entries include counts at risk and counts with events for the usual-care group; no participants are listed at risk in the acupressure arm. These entries cannot be used to estimate a comparative risk from the posted results.
For count outcomes in other settings, over-dispersion can matter when observed variability exceeds what a simple count model expects. In general, allowing for over-dispersion can change uncertainty estimates and tests. The registry record does not report a count model or an over-dispersion assessment, and none should be presumed to have been used.
The record does not state whether analyses were intended to follow an intention-to-treat or another analysis population, how missing data would be handled, or whether interim analyses were planned. Those omissions limit reconstruction of a statistical analysis plan. They do not justify assuming that a particular method was used.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Arm II (Usual Care) | 3 | 3 | 100.0% | 29.2% to 100.0% | 43.9% to 100.0% | 39.8% to 99.4% |
R code and output
arm <- c("Arm II (Usual Care)")
n <- c(3)
events <- c(3)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Arm II (Usual Care) 3 3 100.0 29.2 100.0 43.9 100.0 39.8 99.411. Multiplicity, Missing Data and Analysis Populations
The registry record lists 4 secondary outcome entries, including change in appetite and change in body weight, each appearing twice. It does not report the analysis plan for these outcomes, their timing, or whether any adjustment for multiple comparisons was planned. When several outcomes or repeated comparisons are examined, the chance of at least one apparently notable result can increase. In general, a prespecified approach to multiplicity helps readers understand how multiple tests were handled. No such approach is reported in the registry record.
No results are posted for the listed secondary outcomes, and no statistical analyses are posted. This means there is no basis to describe the size, direction, or precision of changes in appetite or body weight. The record does not report the amount or pattern of missing outcome data, so it is not possible to determine how missingness may have affected any intended analysis.
The registry record also does not report the analysis population, such as whether all randomized participants were intended to be included in a particular analysis. The enrollment and arm counts identify 3 participants, all in usual care, but do not specify an analysis rule. No assumptions about exclusions, adherence, or missing-data procedures should be made.
In general, missing-data methods rely on assumptions about why data are absent and how that absence relates to observed or unobserved outcomes. Those assumptions can affect conclusions. Here, no missing-data method or analysis population is reported, and the lack of an intervention-arm result means that a comparative analysis is unavailable regardless.
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 |
|---|---|---|---|
| Arm II (Usual Care) | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm I (Acupressure Therapy) | 0 of 0 |
| Arm II (Usual Care) | 1 of 3 |
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 |
|---|---|
| Arm I (Acupressure Therapy) | 0 of 0 |
| Arm II (Usual Care) | 0 of 3 |
The registry safety entries list 3 participants at risk in the usual-care arm and none in the auricular acupressure arm. Among the usual-care participants, the record lists 0 serious adverse events, 0 other adverse events, and 1 death. It lists no serious events, other events, or deaths for the acupressure arm, where 0 participants were at risk.
These are counts, not comparative rates. With no participants in the intervention arm, the entries cannot show whether safety differed between the arms. The registry record does not describe the method or period of adverse-event collection, and it does not report whether the death was related to cancer, treatment, study procedures, or another cause. The death count should not be interpreted as an attribution to usual care or to study participation.
Zero recorded events among 3 participants does not establish that an event could not occur in a larger group. Small counts provide limited information about uncommon events, and the record does not provide uncertainty intervals. The safety information is therefore descriptive and incomplete for comparative interpretation.
13. What the Result Does, and Does Not, Mean
The posted results document enrollment of 3 participants in a randomized feasibility study that is now listed as terminated. All 3 are assigned to usual care, and none are listed in the auricular acupressure arm. The registry record specifies an accrual goal of 5 patients/month over a 15-month period, but does not report the average monthly rate. It also does not state why the study was terminated.
These registry entries do not answer whether auricular acupressure improves appetite or body weight. Although changes in appetite and body weight appear among the secondary outcomes, their results are not reported. There is no posted treatment-effect estimate, no uncertainty interval, and no statistical comparison between groups. The absence of a comparison is not evidence that the intervention and usual care have identical outcomes.
The record also does not establish whether the intervention was acceptable, whether recruitment was feasible in the investigators' intended sense, or why all randomized participants were assigned to usual care. Those questions require information that is not reported in the registry record. The posted counts alone do not explain the study's operational course.
The safety entries record no adverse events among the usual-care participants and one death. They do not identify the cause or relationship of the death, and they cannot support a comparison with the acupressure arm because no participants are listed there. They should be read as limited descriptive counts, not as evidence that either arm is safer.
The main statistical conclusion is therefore about the limits of the available evidence: this record documents a small enrollment and an allocation pattern that prevents an intervention-versus-usual-care analysis. It should not be used to make a claim about clinical benefit, lack of benefit, or comparative safety.
14. Why This Trial Matters Statistically
Feasibility studies address practical questions that must be answered before a larger comparative trial can produce a useful estimate of treatment effects. Recruitment is one such question. The registry record makes the accrual goal explicit: 5 patients/month over a 15-month period. It reports 3 enrolled participants but does not report the average monthly accrual rate or explain the study's termination. This makes the distinction between a planned benchmark and an observed feasibility result especially important.
The allocation record also demonstrates why enrollment totals alone are not enough for evaluating a randomized study. All 3 participants were assigned to usual care, with none assigned to auricular acupressure. Even when a trial is described as randomized, a treatment comparison requires usable outcome information from both arms. No intervention effect on appetite, body weight, or safety can be estimated from these posted arm counts.
For statistical readers, the study illustrates how a registry record can document a design and planned outcomes without reporting the analysis needed to answer the clinical question. The listed secondary outcomes and feasibility objective describe what the study aimed to assess; they are not substitutes for results. The lack of posted analyses also limits assessment of precision, missing data, multiplicity, and the intended analysis population.
These distinctions matter for evidence synthesis and future study planning. Descriptive enrollment and safety counts may inform understanding of what was recorded, but they do not support conclusions about efficacy or comparative safety. Transparent reporting of reasons for termination, accrual over time, participant acceptability, and outcome analyses would be needed to evaluate more fully what the study established.
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.
Enrollment was 3 participants, and the registry lists 0 in the auricular acupressure arm and 3 in usual care. This allocation leaves no intervention-arm outcomes for a comparison. The registry record does not explain why all randomized participants were assigned to usual care or why the study was terminated.
The primary endpoint is described as an average accrual rate, but the record posts a participant count rather than a monthly rate. It does not report accrual over time, the number screened or eligible, or reasons people did not enroll. The stated goal of 5 patients/month over a 15-month period therefore cannot be evaluated directly from the posted primary result.
Although the registry lists changes in appetite and body weight as secondary outcomes, it does not post their results. It also does not report the timing or instruments for these outcomes, or details of questionnaire administration. The registry does not report acceptability findings, the reason for termination, or a statistical analysis plan.
The description of double masking does not identify who was masked. Eligibility details beyond the listed cancer types and stages are not reported. The safety entries include one death in usual care but do not report cause or attribution. No adverse-event collection period or comparative safety analysis is reported.
These limitations mean the record supports only a narrow descriptive account of enrollment, allocation, and posted safety counts. It does not support conclusions about treatment effects, the planned accrual rate, or the reasons the study ended.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer — NCT05911243.
- Registry record last updated 2026-11-03; status last verified 2026-10.
- Results first posted 2026-11-03.
- 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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19. Record Summary
The registry record describes a randomized, double-masked, parallel-group pilot and feasibility study sponsored by the University of Washington. It concerns auricular acupressure plus usual care compared with usual care for people with stage II-IV gastric, esophageal, or pancreatic cancer. The primary endpoint is accrual, with a goal of 5 patients/month over a 15-month period.
The study started on 2024-07-22, has a listed primary completion date of 2025-07-09, and is marked terminated. Enrollment is 3. All randomized participants were allocated to usual care: 0 are listed in the acupressure arm and 3 in usual care. The record lists appetite and body-weight changes as secondary outcomes but posts no statistical analyses or outcome comparisons. The reason for termination and the average monthly accrual rate are not reported in the registry record.