Pediatric Oncology Nutrition Intervention Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pediatric Oncology Nutrition Intervention Trial (NCT06175273), a randomized phase 2, phase 3 study. The primary outcome is Body Composition.

2. Clinical Question

The POINT trial aimed to examine changes in body composition, weight status, and nutritional status across common nutrition interventions for pediatric cancer patients. Its stated broader purpose was to inform clinical nutrition guidelines. The primary outcome focused on quadriceps muscle layer thickness, measured by ultrasound and reported as change from baseline in centimeters. Other listed outcomes included weight, body mass index, biomarkers, physical activity, and intervention intolerances.

The central question is therefore about changes in a body-composition measure over follow-up, not just whether an intervention was assigned. The record identifies a randomized, parallel-group trial, but it does not provide the numerical outcome findings needed to judge the size or precision of any group differences. In particular, it notes that the Enteral Nutrition Arm had no enrolled participants. The record does not report whether the primary outcome was analyzed for the other groups, what comparisons were planned, or how the interventions performed relative to Standard of Care.

3. Trial Design

The registry record describes the Pediatric Oncology Interventional Nutrition Therapy (POINT) Trial as a pilot study. It lists the trial as Phase 2 and Phase 3, randomized, parallel-group, and unmasked. The enrollment is listed as 20, and the status is Completed. The recorded start date is 2024-01-31 and the primary completion date is 2025-08-04.

The listed interventions were Oral Nutrition Supplement, Tube Feed, cyproheptadine, olanzapine, and Standard of Care. The arm descriptions group the supplements, tube feeding, and appetite stimulants as nutrition approaches, with Standard of Care identified as the control. The appetite-stimulant description specifies cyproheptadine for participants aged 2-12 years and olanzapine for those >12 years. The oral supplement description says it was intended to meet a minimum of 50% of estimated energy needs, while the enteral-feeding description also specifies a minimum of 50% of estimated energy needs. The oral-supplement description is truncated in the registry record, so its full dosing instructions are not available there.

The primary outcome was change in quadriceps muscle layer thickness, measured by ultrasound and reported in centimeters. The stated timeframe was baseline, 3 months after baseline, and 6 months after baseline. The primary-outcome population note says there were no participants enrolled in the Enteral Nutrition Arm. This is important for interpreting any comparison involving that intervention: the record does not provide an enrolled group from which an outcome estimate could be obtained.

The registry record does not report the randomization method, allocation concealment, eligibility criteria, or a statistical analysis plan. It also does not explain how the study's pilot designation relates to its Phase 2 and Phase 3 classifications. Those design details should not be inferred from the trial title or listed interventions.

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: Participants were randomized at study enrollment. Oral Nutrition Supplements, Enteral Nutrition, and Appetite Stimulants represent protocol-defined nutrition interventions that were implemented after randomization only if participants met prespecified clinical criteria (\>10% weight loss/insufficient energy intake). No participants were enrolled directly into these intervention groups.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: There were no participants enrolled in the Enteral Nutrition Arm.

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: There were no participants enrolled in the Enteral Nutrition Arm. Participants were randomized at study enrollment. Oral Nutrition Supplements, Enteral Nutrition, and Appetite Stimulants represent protocol-defined nutrition interventions that were implemented after randomization only if participants met prespecified clinical criteria (\>10% weight loss/insufficient energy intake). No participants were enrolled directly into these intervention groups.

6. Primary Endpoint

The registry lists the primary outcome as Body Composition, measured over Baseline, at 3 and 6 months after baseline.

The primary endpoint is change in quadriceps muscle layer thickness, measured by ultrasound and reported in centimeters. The registry lists measurements at baseline and at 3 and 6 months after baseline. It describes the endpoint as a change from baseline, but it does not provide numerical values for any of these time points or for the changes.

As a general measurement concept, muscle thickness can serve as an indicator of one aspect of body composition. Tracking a muscle measure over time is relevant to a study whose stated focus includes muscle loss, malnutrition, and nutritional status. Ultrasound provides a way to measure the specified muscle layer, while expressing change from baseline focuses attention on how the measure shifts during follow-up rather than on a single measurement alone. This endpoint is one component of body composition; it does not, by itself, represent every aspect of nutritional status or clinical outcome.

The record does not describe measurement procedures in detail, such as who performed the ultrasound assessments, whether assessors were trained or blinded, or how repeatability was evaluated. It also does not report the observed endpoint values, variability, confidence intervals, or statistical tests. The endpoint's scientific relevance can be understood from the stated study objective, but its results cannot be interpreted without the posted analysis data.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group trial with no masking. In a randomized study, assignment is intended to reduce systematic differences between groups at the point of allocation. A parallel-group design assigns participants to a group that remains their group for the comparison, rather than having each participant receive multiple treatments in sequence. These are general explanations of the design terms. The registry record does not describe the method used to generate the random sequence, how assignments were concealed, or how allocation was implemented.

The record says masking was none. In general, an unmasked study means participants and/or study personnel are not kept unaware of intervention assignment, though the record does not specify which individuals knew assignments. Lack of masking can matter when outcomes involve judgment, adherence, or decisions about care. The primary endpoint is an ultrasound measurement, but the record does not say whether those measuring or interpreting the images were aware of group assignment. It also does not report procedures to limit measurement bias.

The primary outcome is continuous: change in quadriceps muscle layer thickness, measured in centimeters. The record characterizes the outcome as a mean with standard deviation. In general, a mean describes the arithmetic average of measurements, while a standard deviation describes how spread out individual measurements are around that average. A mean alone does not show how variable the participant-level measurements were. Neither the means nor the standard deviations for the primary outcome are reported in the registry record.

The outcome timeframe includes baseline, 3 months after baseline, and 6 months after baseline. For repeated measurements, an analysis may compare changes over time, compare groups at a follow-up time, or model the pattern across all time points. These are general approaches, not a description of the analysis used in this trial. The registry record does not report the statistical model, the exact contrast of interest, whether baseline values were adjusted for, or how measurements from the same participant were handled.

A confidence interval is a statistical range that expresses uncertainty around an estimate under a specified method. It is generally more informative about precision than a significance test alone because it communicates both the estimated value and the range of values compatible with the data. The record does not report confidence intervals for the primary outcome. It also does not list a test statistic or p-value for the primary outcome, so statistical evidence for a difference cannot be assessed from the registry record.

The registry lists 25 outcome measures. When multiple outcomes or comparisons are examined, the chance of finding at least one apparently notable result can increase. As a general statistical approach, multiplicity procedures can adjust interpretation or testing to account for a family of comparisons. The registry record does not report whether any adjustment was planned or used. The existence of multiple registered outcomes does not by itself reveal which outcomes were analyzed or how the analysis was conducted.

Over-dispersion is a general issue for count outcomes when variability exceeds what a simple count model assumes. It can make standard errors too small if not handled appropriately. The primary endpoint is a continuous measurement, not a count outcome, and the registry record does not report a count-model analysis. No conclusion about over-dispersion is warranted for this endpoint.

The sample-size assumptions describe planning illustrations based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. In general, such illustrations estimate the participants per arm that would be needed under those assumptions to detect an effect at a specified power. They are not the trial's observed power, do not establish the trial's original design rationale, and are not evidence of an outcome. The registry record does not report the trial's own sample-size justification. The primary-outcome analysis is not reduced to one comparison because it has several categories or time points, so a single comparison should not be inferred from that planning framework.

Finally, the registry record does not report the analysis population, missing-data method, or whether participants were analyzed according to their randomized assignments. Those choices can affect interpretation. Without them, and without outcome estimates, the statistical methods used to reach any treatment comparison cannot be reconstructed from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 25 outcome measures, including intervention intolerances and changes in weight, body mass index, IL-6, leptin, total cholesterol, cystatin-C, and physical activity. The primary endpoint also includes multiple time points: baseline and follow-up at 3 and 6 months. When many outcomes, time points, or group comparisons are considered, multiplicity becomes relevant. As a general statistical matter, the more comparisons examined, the greater the possibility that some appear notable by chance. The registry record does not report a multiplicity strategy or identify a prespecified family of tests.

The record does not report how missing outcome measurements were handled. It does not state whether the analysis used complete cases, imputation, a repeated-measures method, or another approach. It also does not report how many participants had endpoint measurements at each time point. The absence of an Enteral Nutrition Arm enrollment is explicitly noted for the primary outcome, but the record does not give the available outcome counts for the other arms.

The analysis population is not reported in the registry record. In particular, it does not say whether analyses followed randomized assignment, included only participants who received an intervention, or used another population definition. The record also does not report exclusions from analysis or how protocol deviations were treated. These details matter because analysis populations and missing-data assumptions affect the meaning of an estimated group difference.

No primary-outcome analysis results are listed, so the number of outcomes registered should not be mistaken for the number analyzed. The registry record does not report the statistical analysis plan, multiplicity handling, missing-data approach, or analysis population.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The posted safety figures list serious and other adverse events separately, with the number at risk and the number affected for each group. For Control, 15 were at risk for serious events and 0 were affected; the figures for other events are also 15 at risk and 0 affected. For Oral Nutrition Supplements, 1 was at risk and 0 were affected for serious events, and the other-event figures are 1 at risk and 0 affected. For Enteral Nutrition, the number at risk and affected is 0 for both serious and other events. For Appetite Stimulants, 1 was at risk and 0 were affected for serious events, and the other-event figures are 1 at risk and 0 affected. The listed death count is 0 in each group.

These are the event counts and denominators reported in the registry record; they are not estimates of comparative safety. In particular, the record lists no participants at risk in the Enteral Nutrition group, so the absence of affected participants in that group does not describe an observed group of treated participants. The listed risk denominators also do not account for all 20 enrolled participants, and the reason for this is not reported in the registry record.

Zero affected participants in the listed groups means that no serious or other adverse events were recorded among the stated at-risk counts. It does not establish that an intervention has no safety risks. The record does not provide event descriptions or a top serious-event term, and the small listed denominators limit what these counts can establish.

12. What the Result Does, and Does Not, Mean

The registry record establishes that the POINT trial was listed as a completed, randomized, parallel-group pilot study with 20 participants enrolled. It identifies nutrition interventions of interest and defines change in quadriceps muscle layer thickness as the primary outcome, assessed by ultrasound at baseline and at 3 and 6 months after baseline. It also lists a range of secondary outcomes related to nutrition, biomarkers, physical activity, and intervention intolerance.

Those design details do not establish what happened to participants' muscle thickness or whether outcomes differed across groups. The registry record does not report the numerical primary-outcome results, secondary-outcome findings, or statistical comparisons. It therefore cannot support a conclusion about the size, direction, or precision of any intervention-associated change. In addition, the record explicitly notes that no participants were enrolled in the Enteral Nutrition Arm, so that arm cannot contribute a primary-outcome estimate based on enrolled participants.

These limitations should not be read as evidence that an intervention did or did not affect body composition. They indicate that the results needed to answer that question are not reported in the registry record. Likewise, the listed adverse-event counts describe the recorded events and risk denominators, but do not demonstrate the absence of risk or allow a robust comparison across groups.

The trial's stated aim was to inform clinical nutrition guidance for pediatric oncology. The registry record describes that aim, but it does not report the outcome analyses needed to determine what guidance the findings might support. A completed status indicates the recorded trial status; it does not substitute for posted numerical results, methods of analysis, or uncertainty estimates.

13. Why This Trial Matters Statistically

This trial addresses a difficult measurement and evidence problem: nutritional interventions in pediatric oncology can be evaluated through outcomes that span body composition, weight, biomarkers, and activity. The registry record makes the primary body-composition measure explicit: change in quadriceps muscle layer thickness, assessed by ultrasound. That clarity matters statistically because an interpretable result depends on knowing what was measured and when, not only which intervention was assigned.

The trial is also described as a pilot study and lists 20 participants enrolled. Pilot studies can be important for assessing the feasibility of a research question and informing further study, but the registry record does not report feasibility outcomes or a sample-size justification. It therefore does not establish what precision or level of evidence the study was designed to provide. Any planning illustration based on an observed effect should be understood as a planning aid, not as observed power or proof of an intervention effect.

For interpretation, the absence of reported endpoint estimates is consequential. Means, variability, and uncertainty intervals would show how much the muscle-thickness measure changed and how precisely that change was estimated. Without those results, readers cannot evaluate the magnitude or reliability of a group comparison. The note that the Enteral Nutrition Arm had no participants further limits which intervention comparisons can be supported by enrolled participants.

The record's many listed outcomes also make transparent analysis plans important. Prespecified priorities and clear reporting of missing data, analysis populations, and multiplicity handling help readers distinguish confirmatory findings from exploratory ones. Those details are not reported in the registry record. The trial's subject matter is statistically important, but the recorded information does not supply the estimates needed to quantify its primary question.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main trial-specific limitation in the registry record is the absence of numerical outcome results. Although the study is marked Completed and the primary endpoint and follow-up times are identified, there are no reported group summaries, changes from baseline, uncertainty intervals, or statistical tests for quadriceps muscle layer thickness. The same restriction applies to the listed secondary outcomes in the record used for this analysis.

The registry states that no participants were enrolled in the Enteral Nutrition Arm. That prevents an outcome estimate based on enrolled participants for that intervention and limits the scope of comparisons that can be made. The record does not explain why the arm had no participants or how this affected the trial's planned comparisons.

The enrollment is listed as 20, but the record does not describe the sample-size rationale. It does not provide sufficient information to determine the number of participants with outcome measurements at each time point, the extent of missing data, or whether the analysis population matched the enrollment population. The safety denominators listed by arm also do not account for all 20 enrolled participants; the reason is not reported in the registry record.

Important methodological details are not reported, including eligibility criteria, randomization procedures, allocation concealment, ultrasound measurement procedures, analysis models, missing-data methods, multiplicity handling, and the analysis population. The oral-supplement arm description is truncated, limiting interpretation of its full regimen. These gaps prevent reconstruction of the planned and completed analyses, and they make it inappropriate to infer comparative effects from the design description alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pediatric Oncology Nutrition Intervention Trial — NCT06175273.
• Registry record last updated 2026-10-08; status last verified 2026-09.
• Results first posted 2026-10-08.
• 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.

18. Record Summary

The POINT trial is listed as a completed, randomized, parallel-group, unmasked pilot study with Phase 2 and Phase 3 classifications. The registry record lists 20 participants enrolled. Interventions included oral nutrition supplements, enteral nutrition, appetite stimulants, and Standard of Care.

The primary outcome was change in quadriceps muscle layer thickness, measured by ultrasound in centimeters at baseline and at 3 and 6 months after baseline. The record notes that no participants were enrolled in the Enteral Nutrition Arm. It lists 25 outcome measures, but does not report numerical primary-outcome results, statistical comparisons, missing-data methods, multiplicity handling, or the analysis population. Safety figures list zero affected participants for serious and other adverse events in the stated at-risk groups, with zero deaths listed in each group.