Reducing Frailty for Older Cancer Survivors Using Supplements: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Reducing Frailty for Older Cancer Survivors Using Supplements (NCT04553666), a randomized phase 2 study. The primary outcome is The Proportion of Participants That Completed the Study.

2. Clinical Question

This was a pilot randomized controlled trial focused on feasibility, safety, and preliminary effects of EGCG in this population. For the posted primary endpoint, the registry records a proportion of 1.0 for the intervention group and 1.0 for usual care, with 7 participants listed in each outcome arm. Those values describe the recorded completion outcome. They do not, by themselves, answer whether the intervention changed health or function, and the registry record does not report an inferential comparison between the groups.

3. Trial Design

The registry identifies this study as a phase 2, randomized, parallel-group trial and gives its status as completed. The study title and description characterize it as a pilot trial intended to examine feasibility, safety, and preliminary effects of EGCG in pre-frail and frail older cancer survivors. The registry reports an enrollment of 24. For the primary outcome, the posted arm records list 7 participants in the intervention group and 7 in the usual-care group. The registry record does not explain how these arm-level outcome counts relate to the overall enrollment count.

The intervention group was assigned EGCG and vitamin C: four 200mg EGCG pills and one 250mg vitamin C pill taken once each day. The usual-care group received no study pills. The brief study description specifies twelve weeks of oral supplementation. The primary outcome timeframe is recorded as 12 week, with completion defined by return for the post-intervention visit relative to randomization.

Masking is listed as none. This means the registry describes the trial as unmasked; details about who knew assignment or how outcome assessment was conducted are not reported in the registry record. The method for generating the random allocation sequence, allocation concealment, and any procedures for maintaining group balance are also not reported in the registry record.

The registry lists five outcome measures, while no secondary outcome results are posted. It records no analysis entries. The record does not report a sample-size justification, a detailed analysis plan, or how any deviations from the assigned intervention were handled. These omissions limit the amount that can be said about the trial's design and analysis beyond its stated randomized parallel structure and the posted completion result.

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: Sixty four (64) potentially eligible participants were approached and 24 participants were consented. Of the 24 consented subjects: 5 screen failed (participant was consented but didn't fully meet eligibility criteria e.g. meet frailty cut off or liver toxicity screen); 4 screen withdrew (participant was consented but withdrew from the study before the baseline visit for randomization), and 1 was lost to follow up. Fourteen (14) participants were randomized to the treatment groups.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Since this outcome measure looks at the number of participants approached versus consented, the number of participants analyzed was the 64 approached instead of the 14 that were randomized.

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 14 subjects whose baseline measurements were received.

6. Primary Endpoint

The registry lists the primary outcome as The Proportion of Participants That Completed the Study, measured over 12 week.

The primary endpoint is the proportion of participants who completed the study. The registry describes completion as comparing the number of participants randomized with the number who returned for the post-intervention visit. Its timeframe is 12 week. This is a binary outcome at the participant level: each participant either meets the completion definition or does not, and the result is expressed as a proportion.

In a pilot study, completion can describe whether participants remain engaged through the planned follow-up and whether the study procedures are workable. It is a feasibility measure, not a direct measure of frailty, inflammation, cancer outcomes, or quality of life. The registry identifies the study as examining feasibility and safety, so completion is aligned with the stated pilot purpose.

The posted result records a proportion of 1.0 for the intervention group and 1.0 for the usual-care group; each arm lists 7 participants for this outcome. The registry record does not report confidence intervals, a numerator-and-denominator presentation, or a statistical test for the difference between arms. It also does not describe how the endpoint was handled if a participant had partial follow-up or an incomplete visit. Consequently, the endpoint definition is clear at a broad level, but the record does not provide details needed to assess every operational or analytical decision behind the completion classification.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is completion?

The primary outcome is a binary participant-level endpoint summarized as a proportion. A binary endpoint classifies each participant into one of two states under a defined rule. Here, the rule is completion of the study, described as returning for the post-intervention visit compared with the number randomized. The registry posts a proportion of 1.0 for each arm and lists 7 participants in each arm's outcome record.

For a proportion, the denominator is central to interpretation. It identifies the group of participants from whom the observed proportion was calculated. The arm records list 7 participants each, but the registry record does not separately give a count of participants who completed and a count who did not, or explain how the outcome denominator was selected. Because the overall enrollment is reported as 24, while the arm-level outcome counts are reported separately, readers should not assume that the outcome records account for every enrolled or randomized participant without further information.

What does an arm-level proportion tell us?

A proportion describes the frequency of an outcome in the group to which it applies. It is a descriptive summary, not automatically a comparison between groups. To compare randomized groups statistically, an analysis would normally estimate a contrast, such as a difference in proportions, and quantify uncertainty around that contrast. The registry record does not report such an estimate for this endpoint; it indicates that a two-arm comparison was missing or not estimable for the binary percentage outcome.

In general, an uncertainty interval around a proportion or a group contrast helps show how much information the observed data contain. A narrow interval indicates greater precision under the analysis assumptions, while a wide interval indicates less precision. This is a general statistical interpretation, not an interval reported for this trial. The registry record does not report confidence intervals for the completion result. A point value alone cannot communicate the full uncertainty of an estimate.

Why does the pilot context matter?

This trial is described as a pilot randomized controlled trial of feasibility, safety, and preliminary effects. Pilot studies are often used to describe whether study procedures can be carried out and to develop questions for later evaluation. A pilot's descriptive outcome should not be mistaken for a definitive test of treatment effect. The completion endpoint addresses follow-up participation under the study procedures; it does not measure whether EGCG changed frailty or another clinical condition.

Random assignment can support a fair comparison when the allocation process is adequately implemented and the analysis respects the design. The registry states that allocation was randomized and that the model was parallel, but the sequence-generation method and allocation concealment are not reported in the registry record. The record also lists no masking. These details matter when assessing potential sources of bias, but their absence from the registry record does not establish which procedures were or were not used beyond the listed design features.

How should the planning assumptions be read?

The registry's planning description specifies a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It describes the target effect as a stated fraction of the observed effect. The record does not report an estimable two-arm comparison for this binary endpoint, and the corresponding numerical planning values are not reported in the registry record. A sample-size planning illustration, when available, is a hypothetical design calculation; it is not observed power and does not describe the probability that this completed study detected an effect.

In general, sample-size calculations depend on assumptions about the outcome, the contrast worth detecting, variability, allocation, and the chosen error rate. If an assumed effect is based on an observed pilot effect, that estimate may be unstable, particularly when the pilot contains few outcome observations. A planning illustration based on such an effect is useful only as an illustration of assumptions, not as a guarantee of precision or as a substitute for a prespecified design rationale. The registry record does not report the trial's own sample-size justification.

What can be said about analysis choices?

The registry lists no analysis entries. It does not report a statistical model, an adjustment strategy, a primary analysis population, or a method for handling missing endpoint data. It also does not report whether the analysis followed randomized assignment or used another population definition. These are relevant details because the interpretation of a randomized comparison depends not only on the outcome values but also on who is included and how participants with unavailable outcomes are treated.

In general, missing outcome data can affect a proportion if participants without endpoint information are excluded, counted as not completing, or handled through another method. Different approaches can answer different questions and can lead to different estimates. The registry record defines completion by a return visit, but does not describe the treatment of participants whose visit status was unknown or otherwise unavailable. No particular missing-data method should be inferred.

Multiplicity refers to the challenge of interpreting statistical tests when several outcomes or comparisons are evaluated. The registry lists five outcome measures, but no secondary outcome results or analysis entries are posted. It does not report whether multiplicity was planned or addressed. Because there is no posted inferential comparison for the primary endpoint, a multiplicity-adjusted interpretation cannot be reconstructed from the record.

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.

R code and output

arm    <- c("Intervention Group", "Usual Care Group")
n      <- c(7, 7)
events <- c(0, 0)
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  Intervention Group  7  0  0.0  0.0  41.0  0.0  35.4  0.3  36.9
ARM  Usual Care Group  7  0  0.0  0.0  41.0  0.0  35.4  0.3  36.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures, but reports no secondary outcome results. It records zero analysis entries. This means the posted record does not provide a set of secondary estimates or tests from which to assess the overall pattern of outcome findings. The registry record does not report a prespecified hierarchy of outcomes, a multiplicity adjustment, or how the primary and secondary measures were to be interpreted together.

In general, multiplicity arises when researchers evaluate several outcomes, time points, groups, or statistical contrasts. Repeated testing can increase the chance of finding an apparently notable result by chance if each test is interpreted in isolation. Approaches to multiplicity depend on the study's objectives and analysis plan. No particular approach should be attributed to this trial, because it is not reported in the registry record.

The primary completion result is reported by arm, but no two-arm comparison is available. The registry indicates that the comparison was missing or not estimable for this binary percentage endpoint. It does not report an inferential test, confidence interval, or analysis population. The registry describes the endpoint in terms of participants randomized and those returning for the post-intervention visit, but does not explain how missing or uncertain visit status was handled.

In general, missing-data decisions can affect both the denominator and the interpretation of a proportion. An analysis restricted to participants with documented visits answers a different descriptive question from one that classifies every randomized participant under a stated rule. The registry record does not report which approach was used, nor does it report sensitivity analyses for missing data. It also does not state whether results were analyzed according to randomized assignment. These omissions limit assessment of potential attrition and analysis-population effects; they do not establish that any particular method was used.

12. 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 1% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for 7 participants at risk in each group. It records 0 participants affected by a serious adverse event in the intervention group and 0 in the usual-care group. The death count is 0 in each group. These are the serious-event figures posted for the groups and should be read as event reporting within the recorded participants at risk.

The record also gives figures for other adverse events: 6 affected participants among 7 at risk in the intervention group and 3 affected participants among 7 at risk in the usual-care group. These figures are distinct from the serious adverse-event counts. The registry does not list specific serious adverse-event terms. Further detail on the types, timing, severity, duration, or attribution of the other adverse events is not reported in the registry record.

In general, a zero count in a small study does not establish that an event cannot occur or that risk is absent. It describes what was observed and reported among the participants represented in that record. Event counts also do not, by themselves, show whether a difference between groups is meaningful or attributable to the intervention. No inferential safety comparison is reported, and the safety figures should be interpreted as descriptive rather than as proof of comparative safety.

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

The primary posted outcome indicates that the registry recorded a completion proportion of 1.0 in both the intervention and usual-care groups. Each group has 7 participants listed for this endpoint. This is a descriptive result for return to the post-intervention visit under the study's completion definition. The registry record does not provide a confidence interval or a statistical comparison between groups, so it does not quantify the precision of a group contrast.

The result does not establish that EGCG plus vitamin C affected completion, because the posted proportions are not accompanied by an inferential analysis. It also does not establish that the groups are equivalent. Similar point estimates do not prove equivalence; an equivalence assessment would require an appropriate prespecified framework and uncertainty estimates, which are not reported in the registry record.

Completion is a feasibility-related outcome. It does not directly measure changes in frailty, inflammation, cancer status, or any other clinical outcome. Although the study title and summary refer to preliminary effects, the primary result presented is about study completion. No secondary outcome results are posted, and there are no registry analysis entries from which to assess other effects.

The serious adverse-event record lists no affected participants and no deaths in either group among the participants at risk recorded for those outcomes. Other adverse events are also listed, with the reported counts differing between groups. The record does not provide enough detail about event type, timing, or attribution to support a broader interpretation of safety. These observations describe this study's posted data and should not be generalized as a guarantee about outcomes in other participants or settings.

Overall, the record supports a narrow descriptive statement about completion and recorded adverse events in a pilot trial. It does not establish treatment efficacy, a causal effect on clinical status, or a definitive comparison of safety. The modest arm-level outcome counts, missing inferential results, and unreported analysis details mean that precision and broader applicability cannot be determined from the registry record.

14. Why This Trial Matters Statistically

This study illustrates why a pilot trial's purpose and its endpoint need to be kept in view when interpreting results. The primary measure is study completion, which addresses whether participants reached the post-intervention visit. That can be relevant to feasibility, but it is not a surrogate for a clinical benefit unless a separate rationale and evidence support that interpretation. A completion proportion should therefore be read as a process outcome rather than as evidence that the intervention changed frailty or another health measure.

The record also demonstrates the difference between arm-level descriptions and a comparative estimate. Proportions of 1.0 are posted for both groups, but a statistical contrast and its uncertainty are not reported. Without those, readers cannot assess the precision of a difference or determine what range of group effects remains compatible with the observed data. A point estimate is not a complete account of evidence.

Small pilot outcome counts make careful reporting especially important. The registry gives an overall enrollment of 24 and lists 7 participants in each arm for the primary outcome, but does not explain the relationship between these counts. Reporting the analysis population, outcome denominator, missing-data handling, and a confidence interval would help readers understand the scope and precision of the result. The registry also does not report the trial's sample-size justification or a full statistical analysis plan.

Finally, the safety figures distinguish serious from other adverse events, but the event descriptions are limited. The record lists no serious events or deaths in the recorded groups while noting other adverse events in both groups. Such findings are descriptive and do not resolve comparative safety. The statistical lesson is that a pilot result can be informative about what was recorded while leaving substantial questions about estimation, uncertainty, and generalization unanswered.

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.

The primary outcome record lists 7 participants in each group, whereas overall enrollment is reported as 24. The registry record does not explain how these counts relate, whether they correspond to a particular analysis population, or why the outcome counts differ from the overall enrollment figure. This limits interpretation of the denominator and of the completeness result.

The result is reported as a proportion of 1.0 in each group without a confidence interval or a posted two-arm comparison. The registry indicates that a comparison was missing or not estimable for this binary percentage endpoint. As a result, the precision of the proportions and any between-group contrast cannot be evaluated from the posted information. The registry record does not report a numerator-and-denominator breakdown for the completion outcome.

The study is described as randomized, parallel, and unmasked, but the random-sequence method and allocation concealment are not reported in the registry record. The record also does not provide a statistical analysis plan, a sample-size justification, a defined analysis population, or a method for handling missing endpoint data. These omissions prevent a fuller assessment of potential bias and of how the reported proportions were obtained.

Although five outcome measures are listed, no secondary results are posted and no analysis entries appear in the record. This restricts interpretation to the primary completion outcome and posted adverse-event counts. The adverse-event information does not include detailed event descriptions, timing, or attribution; no serious-event terms are listed. The registry record also does not report enough participant characteristics or eligibility detail to assess how broadly the findings might apply to older cancer survivors beyond the stated pre-frail or frail population.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Reducing Frailty for Older Cancer Survivors Using Supplements — NCT04553666.
• Registry record last updated 2026-05-07; status last verified 2026-04.
• Results first posted 2024-09-19.
• 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.

19. Record Summary

NCT04553666 is a completed phase 2 pilot randomized parallel-group trial sponsored by the University of Rochester. It concerns EGCG plus vitamin C in pre-frail and frail older cancer survivors, compared with usual care without study pills. The study description specifies daily oral supplementation for twelve weeks, and masking is listed as none.

The primary endpoint is completion of the study, defined by return for the post-intervention visit, with a timeframe of 12 week. The registry records a proportion of 1.0 in each group, with 7 participants listed in each arm for this outcome. No two-arm comparison is reported. The record lists five outcome measures, no secondary results, and no analysis entries. Serious adverse-event and death counts are recorded as 0 in both groups; other adverse events are also reported.

The posted information supports a descriptive account of completion and recorded adverse events. Uncertainty estimates, analysis-population details, missing-data methods, and a sample-size justification are not reported in the registry record.