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 High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients (NCT02932332), a randomized phase 2 study. The primary outcome is Change in Dyspnea Numeric Score Between 0 and 10 Minutes.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02932332 |
| Phase | Phase 2 |
| Condition | Cancer |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Double |
| Enrollment | 26 |
| Arms in the primary outcome | 4 |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Hospitalized cancer patients experiencing shortness of breath were the population of interest. The primary outcome population was narrower: participants who completed the first intervention. The registry record reports enrollment of 26, but does not report how the enrollment count relates to the primary outcome population beyond that stated criterion.
Intervention
The study compared four breathing therapies: high-flow oxygen, low-flow oxygen, high-flow air, and low-flow air. Each participant’s treatment sequence began with one therapy and continued through the other therapies. The primary endpoint concerns the change after the first intervention, from baseline to 10 minutes.
Comparator
The comparator was not a single separate control group. The four reported groups represent different treatment sequences, each starting with a different therapy. The registry describes a crossover design, in which participants receive more than one therapy in sequence. The initial treatment groups therefore describe the first intervention rather than a conventional parallel-group comparison over the whole study.
Primary question
The primary question was how dyspnea intensity changed between baseline and 10 minutes after the first intervention. Intensity was recorded on a numeric scale from 0, meaning none, to 10, meaning worst. The registry also describes a minimal clinically important difference of 1 point. The posted results give a mean change and 95% confidence interval for each initial-treatment sequence; they do not give a reported between-treatment contrast or its confidence interval.
3. Trial Design
NCT02932332, titled High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients, is recorded as a completed, randomized, double-masked, phase 2 crossover trial sponsored by M.D. Anderson Cancer Center. The listed condition is cancer. The registry records a start date of 2016-10-11 and a primary completion date of 2023-03-23. Enrollment is listed as 26.
The study compared high-flow oxygen, low-flow oxygen, high-flow air, and low-flow air. Rather than assigning participants to a single treatment for the entire study, the crossover design arranged therapies in sequences. The four reported sequences began, respectively, with high-flow air, high-flow oxygen, low-flow air, or low-flow oxygen. Each sequence then included the other three therapies. The arm descriptions specify a 10 minute breathing treatment and a 10 minute washout before subsequent treatments; the registry describes a total 80 minute study period.
The primary outcome is change in dyspnea numeric score between baseline and 10 minutes. Its stated population is participants who completed the first intervention, so the posted primary outcome summaries concern the initial treatment period rather than the full sequence of repeated treatments. The reported group sizes for this endpoint are 4, 4, 5, and 4, corresponding to the sequence groups. They should not be interpreted as a complete accounting of trial enrollment.
The registry lists two secondary outcomes: change in Modified Borg Scale intensity and change in Modified Borg Scale unpleasantness between 0 and 10 minutes. It lists three outcome measures in total, but no posted secondary outcome results are included in the registry record. The registry record does not report detailed recruitment flow, the method used to generate or conceal the random sequence, or a fuller account of masking procedures.
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: 19 patients were randomized for this study. 7 patients were not randomized for various reasons (discharged too early=3, changed mind=2 and others =2)
Overall Study
| Stage | Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx) | Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir) | Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) |
|---|---|---|---|---|
| STARTED | 5 | 4 | 5 | 5 |
| Intervention 1 | 4 | 4 | 5 | 4 |
| Intervention 2 | 4 | 3 | 4 | 4 |
| Intervention 3 | 3 | 2 | 4 | 3 |
| Intervention 4 | 3 | 1 | 4 | 3 |
| COMPLETED | 3 | 1 | 4 | 3 |
| NOT COMPLETED | 2 | 3 | 1 | 2 |
Reasons for not completing this period:
| Reason | Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx) | Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir) | Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) |
|---|---|---|---|---|
| Withdrawal by Subject | 1 | 1 | 0 | 1 |
| Chest pain | 0 | 0 | 0 | 1 |
| Not Dyspneic cough | 1 | 2 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants who completed the first intervention.
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: It included all randomized participants
| Characteristic | Unit | Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx) | Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir) | Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 5 | 4 | 5 | 5 | 19 | |
| Age, Continuous | years | 55 (35 to 68) | 48 (29 to 62) | 50 (36 to 59) | 51 (34 to 70) | 51 (29 to 70) |
| Sex: Female, Male: Female | Participants | 2 | 3 | 3 | 3 | 11 |
| Sex: Female, Male: Male | Participants | 3 | 1 | 2 | 2 | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 1 | 1 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 | 4 | 4 | 4 | 17 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 2 | 0 | 4 |
| Race (NIH/OMB): White | Participants | 4 | 3 | 3 | 5 | 15 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 5 | 4 | 5 | 5 | 19 |
| Cancer Stage: II | Participants | 0 | 0 | 0 | 1 | 1 |
| Cancer Stage: III | Participants | 0 | 0 | 1 | 0 | 1 |
| Cancer Stage: IV | Participants | 5 | 4 | 4 | 4 | 17 |
| Cancer Type: Breast | Participants | 0 | 0 | 1 | 1 | 2 |
| Cancer Type: Gastrointestinal | Participants | 3 | 1 | 1 | 2 | 7 |
| Cancer Type: Genitourinary | Participants | 0 | 1 | 1 | 0 | 2 |
| Cancer Type: Gynecological | Participants | 0 | 0 | 1 | 0 | 1 |
| Cancer Type: Hematologic | Participants | 0 | 1 | 0 | 1 | 2 |
| Cancer Type: Thoracic | Participants | 1 | 1 | 1 | 1 | 4 |
| Cancer Type: Other | Participants | 1 | 0 | 0 | 0 | 1 |
| Dyspnea for reason of admission: Yes | Participants | 2 | 1 | 4 | 2 | 9 |
| Dyspnea for reason of admission: No | Participants | 3 | 3 | 1 | 3 | 10 |
| Supplement Oxygen: Yes | Participants | 3 | 1 | 3 | 2 | 9 |
| Supplement Oxygen: No | Participants | 2 | 3 | 2 | 3 | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Dyspnea Numeric Score Between 0 and 10 Minutes, measured over 0 (baseline) minutes and at 10 minutes.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in dyspnea intensity from baseline to 10 minutes after the first intervention. The measure is a numeric rating scale from 0 to 10, where 0 means no dyspnea and 10 means the worst dyspnea. The registry identifies 1 point as the minimal clinically important difference. This threshold gives context for interpreting the scale: it is the stated amount of change considered important, not a claim that any observed group mean change reached that threshold.
A change score focuses on how a participant’s rating differs between two time points, rather than only describing the rating at one time. The posted group estimates are means, so each is an average change among the participants included in that group’s reported endpoint summary. Negative mean changes indicate that scores were lower at 10 minutes than at baseline on average. They do not show that every individual had a lower score.
The registry’s primary outcome population is participants who completed the first intervention. This makes the endpoint specific to an initial treatment period and does not, by itself, summarize the effects across all periods of the crossover sequence. The registry record does not report participant-level score distributions, baseline values by sequence, or a separate estimate of the contrast between treatments. Those details would help readers assess variation and distinguish the observed within-group changes from a comparative treatment effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome estimates are mean changes in dyspnea score between baseline and 10 minutes for participants who completed the first intervention. For the sequence beginning with high-flow air, the mean change was -1.8, with a 95% confidence interval from -3.0 to -0.5. For the sequence beginning with high-flow oxygen, the mean change was -1.8, with a 95% confidence interval from -2.8 to -0.7. For the sequence beginning with low-flow air, the mean change was -0.6, with a 95% confidence interval from -1.3 to 0.2. For the sequence beginning with low-flow oxygen, the mean change was -0.5, with a 95% confidence interval from -1.0 to 0.1.
All four mean changes are negative, indicating lower average dyspnea scores at 10 minutes than at baseline in these reported groups. The estimates differ in their precision: the confidence intervals are wider for some groups than others, and the reported group sizes are small. A confidence interval describes uncertainty around an estimated mean under the statistical method used; it is not a range containing every participant’s change. The registry does not report the exact method used to construct these intervals.
The confidence intervals for the low-flow groups include 0, while the intervals for the two high-flow groups do not. That distinction concerns uncertainty around each group’s mean change relative to no change. It is not a direct test of whether one treatment is better than another. The registry record does not report a comparative treatment estimate, a test of differences between sequences, or a p-value for the primary endpoint. Overlap or non-overlap between separate group confidence intervals should not be substituted for a formal comparison.
The stated minimal clinically important difference is 1 point. It provides a reference for judging the size of change, but it does not establish that a particular group’s mean change is clinically meaningful for every participant. The posted estimates are group averages, and individual responses may vary. The record does not provide participant-level results or an analysis comparing the observed changes with that threshold.
Because the primary outcome is reported for the first intervention, these data do not directly represent comparisons across all treatment periods in the crossover. The registry record does not report period-specific results, sequence-adjusted estimates, or an analysis addressing possible carryover. The available results therefore support a careful description of short-term mean changes within the initial-treatment groups, not a definitive ranking of the four therapies.
9. Statistical Methods Explained
General explanation: a mean change score is calculated by taking each participant’s later measurement relative to their earlier measurement and averaging those changes within a group. This summarizes the direction and typical size of change, but it conceals variation among individuals. A group mean can be negative even when some participants’ scores rose, and the mean alone cannot show how many participants improved or worsened. The registry reports mean changes, rather than a median or a distribution of individual changes.
The dyspnea scale runs from 0 to 10, with lower scores representing less reported intensity. Thus, a negative change means the 10-minute score was lower than the baseline score on average. This direction is an interpretation of the change measure, not a comparative effect estimate. The observed means are -1.8 for the high-flow air-first and high-flow oxygen-first groups, -0.6 for the low-flow air-first group, and -0.5 for the low-flow oxygen-first group. No arithmetic contrast between these means is reported as a trial result.
General explanation: a confidence interval expresses statistical uncertainty around an estimated quantity, under assumptions of the method used to construct it. A narrower interval indicates greater precision than a wider interval, all else being equal. The intervals around the posted means are 95% confidence intervals. They describe uncertainty in each group’s mean change, not the spread of individual scores, and do not imply that a stated proportion of individual results falls within the interval. The registry record does not report the calculation method, assumptions, or degrees of freedom used for these intervals.
General explanation: a formal comparison of treatment effects typically estimates a contrast between treatments and its uncertainty. Separate mean estimates, even when each has its own confidence interval, do not provide that contrast automatically. The registry lists no analyses for the posted endpoint, and does not report a treatment contrast, associated interval, or p-value. Consequently, the displayed group summaries should be read descriptively rather than as a completed inferential comparison.
The crossover design has a particular statistical structure. Participants receive multiple interventions in an ordered sequence, so measurements may be related within the same participant. General explanation: an analysis of crossover data may need to account for repeated measurements, treatment period, sequence, and possible residual effects of earlier treatments. Accounting for within-participant correlation can affect uncertainty estimates. Whether and how these considerations were handled in the sponsor’s analysis is not reported in the registry record. The primary outcome is specifically limited to those who completed the first intervention, which is different from an estimate using measurements over the full crossover.
The registry’s four groups are defined by the treatment received first and the order of subsequent therapies. For the posted primary endpoint, the reported group sizes are 4 for the high-flow air-first sequence, 4 for the high-flow oxygen-first sequence, 5 for the low-flow air-first sequence, and 4 for the low-flow oxygen-first sequence. The registry does not explain why the endpoint counts differ across these groups or how participants without an endpoint measurement were handled. The record also does not report baseline scores by group, which would be useful context for interpreting change scores.
General explanation: small group sizes tend to make estimates less precise and can make results sensitive to individual observations. The confidence intervals express some of this uncertainty, but they do not address every potential source of bias, such as missing data or departures from the planned analysis. The registry record does not report a sample-size justification, the intended statistical model, or whether any interim analyses were planned or conducted.
The posted sample-size illustration is a planning exercise based on an observed effect, with stated assumptions of a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such an illustration describes a hypothetical planning calculation, not observed power and not the trial’s original design rationale. Its interpretation depends on the assumed fraction of the observed effect and the other stated assumptions. The registry record does not report the study’s own sample-size justification. No numerical planning estimates are restated in this interpretation.
General explanation: over-dispersion is extra variability beyond what a statistical model expects. It matters when a model assumes less variability than the data contain, because standard errors can then be too small and intervals too narrow. The posted primary measure is continuous and summarized as a mean, but the registry does not report a model assessment or a finding about over-dispersion. It would therefore be inappropriate to assert that over-dispersion was present or that a particular correction was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary endpoint and two secondary outcomes: change in Modified Borg Scale intensity and change in Modified Borg Scale unpleasantness between 0 and 10 minutes. It records three outcome measures in total. The registry entries include numerical results for the primary dyspnea numeric score but no results for the secondary outcomes. Their estimates and uncertainty are therefore not reported in the registry record.
When multiple outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase. General explanation: multiplicity procedures can adjust interpretation or statistical testing to account for a planned family of comparisons. The registry record does not report whether a multiplicity adjustment was planned or used, how outcomes were prioritized beyond identifying the primary endpoint, or whether any additional analyses were conducted. No claim about adjusted or unadjusted significance can be made from the posted information.
The primary outcome population is participants who completed the first intervention. The record does not report a fuller analysis-population definition, such as whether the primary analysis followed an intention-to-treat principle, nor does it describe how participants were assigned to analysis populations. The endpoint group sizes are 4, 4, 5, and 4. The registry does not report reasons for missing outcome measurements, the number excluded from each analysis, or any method used to handle missing data.
Missingness can affect interpretation if the people with recorded outcomes differ systematically from those without them. General explanation: complete-case summaries describe those with available measurements and may not represent all randomized participants when missingness is related to outcomes or treatment. The available record does not establish whether such a pattern occurred in this trial. It also does not report sensitivity analyses for missing data, protocol deviations, or analysis-set exclusions. These omissions limit assessment of how robust the results are to incomplete outcome data.
11. 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 |
|---|---|---|---|
| High Flow Air | 0 | 12 | 0.0% |
| High Flow Oxygen | 0 | 13 | 0.0% |
| Low Flow Air | 0 | 13 | 0.0% |
| Low Flow Oxygen | 0 | 13 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| High Flow Air | 0 of 12 |
| High Flow Oxygen | 0 of 13 |
| Low Flow Air | 0 of 13 |
| Low Flow Oxygen | 0 of 13 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| High Flow Air | 7 of 12 |
| High Flow Oxygen | 6 of 13 |
| Low Flow Air | 4 of 13 |
| Low Flow Oxygen | 7 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | High Flow Air | High Flow Oxygen | Low Flow Air | Low Flow Oxygen |
|---|---|---|---|---|---|
| Moisture in nose | Respiratory, thoracic and mediastinal disorders | 7 of 12 | 6 of 13 | 2 of 13 | 5 of 13 |
| Nasal prong uncomfortable | Respiratory, thoracic and mediastinal disorders | 5 of 12 | 5 of 13 | 3 of 13 | 5 of 13 |
| Dry Nose | Respiratory, thoracic and mediastinal disorders | 2 of 12 | 4 of 13 | 2 of 13 | 7 of 13 |
| Anxiety | Nervous system disorders | 4 of 12 | 3 of 13 | 4 of 13 | 1 of 13 |
| Trouble talking | Respiratory, thoracic and mediastinal disorders | 3 of 12 | 2 of 13 | 4 of 13 | 2 of 13 |
| Feeling of suffocation | Respiratory, thoracic and mediastinal disorders | 4 of 12 | 2 of 13 | 2 of 13 | 0 of 13 |
| Dry eyes | Nervous system disorders | 1 of 12 | 2 of 13 | 1 of 13 | 1 of 13 |
| Eye irritation | Nervous system disorders | 0 of 12 | 2 of 13 | 2 of 13 | 0 of 13 |
The registry reports serious adverse events and other adverse events separately for the four therapies. For serious adverse events, the affected count is 0 in each group. The numbers at risk are 12 for high-flow air, 13 for high-flow oxygen, 13 for low-flow air, and 13 for low-flow oxygen. Deaths are recorded as 0 for each group, and no serious adverse event terms are listed.
For other adverse events, the affected counts are 7 of 12 at risk for high-flow air, 6 of 13 for high-flow oxygen, 4 of 13 for low-flow air, and 7 of 13 for low-flow oxygen. These are the registry’s reported counts; no percentages are calculated. The record does not provide event descriptions, severity breakdowns, timing, or a comparative analysis of these counts. It is therefore not possible to determine from these figures alone whether the groups differed in safety outcomes.
General explanation: an observed count of zero serious events does not prove that an event cannot occur, particularly when the numbers observed are limited. Safety counts also depend on how events were defined, collected, and attributed. The registry record does not report those details or the duration of safety follow-up. These figures describe the posted record and should not be treated as a complete account of risk.
12. What the Result Does, and Does Not, Mean
The primary results describe short-term mean changes in dyspnea intensity after the first intervention. The high-flow air-first and high-flow oxygen-first groups each had a mean change of -1.8. The low-flow air-first group had a mean change of -0.6, and the low-flow oxygen-first group had a mean change of -0.5. The reported 95% confidence intervals show uncertainty around each group mean, with differing degrees of precision.
These summaries do not establish that one therapy outperformed another. The registry record does not report a direct comparison between treatments, a treatment-effect estimate, or a statistical test for such a comparison. Nor do the group averages show how each participant responded. Because the primary endpoint is restricted to participants who completed the first intervention, it does not summarize the complete crossover experience or all treatment periods.
The stated 1-point minimal clinically important difference can help readers contextualize the scale, but the registry does not report an analysis that tests the group results against this threshold. A mean change should not be treated as the response of every participant, and a threshold for clinical importance is not the same as evidence of a between-treatment difference.
The registry identifies the trial as completed and reports enrollment of 26. The endpoint summaries are based on the reported groups of 4, 4, 5, and 4. The record does not explain the relationship between enrollment and the endpoint counts, including whether the difference reflects missing measurements, eligibility for the endpoint, or other reasons. The results therefore have limited precision and incomplete information about outcome availability.
In statistical terms, the posted record supports a descriptive account of average score changes in the initial treatment groups. It does not support a definitive comparative conclusion, an assessment of effects over the full sequence, or a broad safety conclusion. Those questions require analyses and reporting that are not present in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because it uses a crossover structure to compare four breathing therapies. In a crossover, treatment order matters to interpretation: a participant’s later measurement may be connected to earlier treatments and to the period in which it was taken. The registry’s primary endpoint, however, is limited to change after the first intervention. That gives a relatively focused short-term summary, while leaving the full sequence comparison dependent on analyses not reported in the registry record.
The posted results also illustrate the difference between estimating change within groups and estimating a treatment contrast. Each sequence has a mean change and confidence interval, but these alone do not answer whether the therapies differ. This distinction is important when readers encounter several arm-level summaries: the statistical question addressed by each estimate must match the question of interest.
The endpoint is a patient-reported symptom measure, with a stated scale range and a stated minimal clinically important difference. That allows the magnitude of average change to be interpreted in the context of the instrument, while still requiring caution about group averages, individual variation, and uncertainty. The confidence intervals make precision visible, but do not replace a comparative analysis.
The reported endpoint groups are small, and the registry does not provide detailed accounting for the difference between enrollment and the available endpoint counts. This makes transparency about analysis populations and missing outcomes especially relevant. The record also lists secondary outcomes without posted results, and does not report multiplicity handling or the planned statistical model.
These features make the study a useful example of why design, estimand, analysis population, uncertainty, and reporting completeness all matter. A trial can pose an important clinical question while its registry summaries answer only part of the statistical question. The appropriate reading is to distinguish observed short-term mean changes from evidence of comparative effects.
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 primary endpoint is reported only for participants who completed the first intervention. The registry does not report a full participant flow or explain how the endpoint groups relate to enrollment of 26. It also does not describe reasons for missing outcome measurements, exclusions, or missing-data methods. This makes it difficult to assess whether the reported participants represent all randomized participants.
The reported primary results are group means and 95% confidence intervals. The registry record does not report participant-level distributions, baseline scores by sequence, or a direct comparison among the four initial treatments. Consequently, readers cannot assess individual response patterns or infer a treatment contrast from the means alone. The group sizes are 4, 4, 5, and 4, limiting precision.
Although the study is described as a crossover, primary endpoint results concern the first intervention rather than all periods. The registry does not report period-specific summaries, sequence-adjusted estimates, or how within-participant correlation and possible carryover were addressed. Details of random-sequence generation, allocation concealment, and masking procedures are also not reported in the registry record.
The registry lists two secondary outcomes but does not include their results in the registry record used for this analysis. It does not report whether multiplicity was addressed, what statistical model was planned, or the study’s sample-size justification. The safety record gives counts but not event descriptions, severity details, timing, or a comparative analysis. Each of these reporting gaps limits the conclusions that can be drawn from the posted summaries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients — NCT02932332.
- Registry record last updated 2023-04-21; status last verified 2023-04.
- Results first posted 2021-09-20.
- 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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18. Record Summary
NCT02932332 is a completed, randomized, double-masked, phase 2 crossover trial sponsored by M.D. Anderson Cancer Center. It studied high-flow oxygen, low-flow oxygen, high-flow air, and low-flow air for shortness of breath in hospitalized cancer patients. The registry lists enrollment of 26.
The primary endpoint was change in dyspnea numeric score from baseline to 10 minutes among participants who completed the first intervention. Mean changes were negative in all four initial-treatment groups, with 95% confidence intervals reported for each. The registry does not report a direct treatment comparison or a p-value for this endpoint. Two secondary outcomes are listed, but their results are not reported in the registry record.
Serious adverse event counts and deaths are recorded as 0 in each group. Other adverse event counts are also reported, but the record does not include detailed event descriptions or comparative safety analyses. Missing-data methods, the full analysis plan, and the study’s sample-size justification are not reported in the registry record.