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 - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX) (NCT01902966), a na na study. The primary outcome is Proportion of Patients Completing Symptom Inventories.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01902966 |
| Phase | NA |
| Condition | Cervical Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Women with advanced, recurrent, incurable cervical cancer. The study was intended to assess whether participants would complete symptom, anxiety and depression, pain, and quality-of-life questionnaires, and whether they would complete the study treatment.
Intervention
Propranolol hydrochloride combined with relaxation and guided imagery sessions. The intervention description specifies a starting dose of 20 mg by mouth twice a day, with a planned increase to 40 mg by mouth twice a day at the start of the second month if the initial dose was tolerated. Participants were to record medication use in a pill diary.
Comparator
There was no comparator group. The registry describes a single-group study and does not report a randomized allocation. The study therefore does not provide a like-for-like comparison between the combined intervention and another treatment or control condition.
Primary question
At 2 months, what proportion of patients completed the symptom inventory, anxiety and depression survey, pain inventory, and quality-of-life surveys? The broader feasibility aims also concerned questionnaire completion and completion of the propranolol and relaxation/guided imagery intervention. The registry states that data were not collected because the protocol was terminated early, so the primary question has no reported outcome estimate.
3. Trial Design
This was a single-group feasibility study of propranolol combined with relaxation and guided imagery in women with advanced, recurrent, incurable cervical cancer. The registry lists cervical cancer as the condition and identifies M.D. Anderson Cancer Center as the sponsor. The study was not a randomized comparison: allocation is recorded as NA, and the registry lists no control arm. Masking is recorded as none.
The intervention combined a drug with behavioral components. The described starting dose was propranolol 20 mg by mouth twice a day. If the initial dose was tolerated, with no hypotension or bradycardia, the described plan was to increase the dose to 40 mg by mouth twice a day at the start of the second month. A pill diary was used to record medication taken each day. Relaxation audio recordings and questionnaires are also listed among the interventions.
The study enrolled 6 participants. Its primary outcome concerned completion of symptom, anxiety and depression, pain, and quality-of-life questionnaires at 2 months. The registry also describes broader aims of assessing questionnaire and treatment completion, as well as possible effects on symptoms, anxiety, depression, pain, and quality of life. Those broader aims are not equivalent to a controlled efficacy comparison.
The status is terminated. The registry says primary outcome data were not collected because the protocol was terminated early. It does not report the reason for termination, a detailed account of treatment exposure, or results for the intended completion outcomes. The registry dates the study start as 2013-09-11 and primary completion as 2020-08-14; those dates do not supply the missing outcome data.
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: 6 patients were registered on this study but only 5 received treatment - 1 patient signed consent but did not receive any treatment on study due to physician decision after consultation with cardiology
Overall Study
| Stage | Propranolol + Relaxation/Guided Imagery |
|---|---|
| STARTED | 5 |
| COMPLETED | 2 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Propranolol + Relaxation/Guided Imagery |
|---|---|
| Death | 1 |
| Physician Decision | 1 |
| Withdrawal by Subject | 1 |
Analysis population for the primary outcome, as defined in the registry: data were not collected due to protocol terminated early.
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: All registered participants.
| Characteristic | Unit | Propranolol + Relaxation/Guided Imagery |
|---|---|---|
| Participants analysed | 6 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 |
| Age, Categorical: >=65 years | Participants | 1 |
| Age, Continuous | years | 50 (31 to 74) |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Patients Completing Symptom Inventories, measured over 2 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the proportion of patients completing symptom inventories and related questionnaires. The registry specifies the symptom inventory, anxiety and depression survey, pain inventory, and quality-of-life surveys, naming MDASI, HADS, BPI, and FACT-Cx. Its stated timeframe is 2 months.
General: In a feasibility study, completion of questionnaires can indicate whether the planned measurement process is workable for the intended participants and setting. A proportion is intended to describe how many participants meet a prespecified completion criterion relative to the relevant group. The registry record does not provide a completion criterion beyond its description of completing the named instruments, and it does not give a denominator or an observed completion proportion for this endpoint.
The endpoint is distinct from a measure of symptom improvement. Questionnaire completion alone would describe whether assessments were completed; it would not establish that symptoms, anxiety, depression, pain, or quality of life changed. Although the registry also expresses interest in possible effects on these outcomes, it reports that primary outcome data were not collected because the protocol was terminated early. No endpoint estimate or uncertainty interval is reported, so the planned feasibility question cannot be answered from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the primary outcome data were not collected. The registry attributes this to early protocol termination. Consequently, no proportion of participants completing the symptom inventories and related surveys is reported for the 2-month timeframe. The record also does not report an estimate of change in symptoms, anxiety, depression, pain, or quality of life. This is an absence of outcome data, not a reported finding that completion was low or that outcomes did not change.
The study enrolled 6 participants, but that enrollment figure cannot substitute for the missing endpoint result. It does not show how many completed any particular questionnaire, how many completed the combined intervention, or how much treatment they received. Those details are not reported in the registry record. The adverse-event figures are separate safety information and do not provide a completion outcome or an efficacy estimate.
The design also limits what could have been concluded even if outcome measurements had been collected. There was a single group and no randomized comparator. General: observed changes in a single group may reflect the intervention, the course of illness, other care, measurement variability, or other influences. Without a concurrent comparison group, these explanations cannot be distinguished reliably by a simple before-and-after contrast. Here, the registry does not report the primary outcome data needed even to describe such a contrast.
No statistical analyses are reported. There is therefore no posted estimate, confidence interval, p-value, or adjusted analysis to interpret for the primary endpoint. General: a confidence interval describes the range of estimates reasonably compatible with the data and a stated statistical procedure; it communicates precision as well as the estimate. Since the registry reports no primary outcome data, there is no interval to assess and no basis for describing the precision of an endpoint estimate.
The appropriate conclusion is narrow: the registry records a feasibility study that ended before primary outcome data were collected. It does not establish the questionnaire completion rate, intervention completion rate, or an effect on clinical or patient-reported outcomes. The available record also does not explain why the study was terminated early, so the reason should not be inferred from the missing results.
9. Statistical Methods Explained
Statistical methods help distinguish what a study planned to measure from what its results can support. In this case, the registry describes a single-group feasibility study, a questionnaire-completion endpoint, and early termination before primary outcome data were collected. No statistical analyses are reported. The following concepts clarify what can and cannot be learned from that record.
What does a single-group design allow?
The registry identifies the study model as single group and allocation as NA. There is no randomized control group or other like-for-like comparator reported. General: a single-group study can describe what happened among participants who were observed, such as whether they completed assessments, if those observations are available. It cannot by itself separate an intervention effect from other changes over time or other influences. Because this record says the primary data were not collected, it does not even provide the planned completion description.
The absence of a comparator matters particularly for the registry’s broader interest in whether propranolol and relaxation/guided imagery may affect symptoms, anxiety, depression, pain, or quality of life. The stated interest is not a result. No causal effect estimate is reported, and the design as registered does not provide a randomized comparison from which to estimate one.
What does the planned proportion represent?
The primary outcome is a proportion of patients completing specified questionnaires at 2 months. General: a proportion summarizes the frequency of a defined outcome in a group. Interpreting it requires knowing what counts as completion and which participants belong in the denominator. The record names the instruments and timeframe, but does not report a completion rule, an observed numerator, or a denominator for this endpoint. The endpoint therefore cannot be reconstructed from the enrollment figure alone.
A proportion is also not a treatment-effect measure by itself. It would address questionnaire completion under the study process, rather than whether the intervention improved symptoms or quality of life. Those questions require their own outcome definitions and data, neither of which is reported as an analyzed result in the registry.
How should uncertainty be understood?
General: an estimate based on a small group is often imprecise, and an interval estimate can show how much uncertainty surrounds it. A confidence interval does not guarantee that the underlying value lies within its bounds; it is interpreted under the assumptions of the statistical method used. In this record, there is no primary outcome estimate and no confidence interval to interpret. It would be inappropriate to invent an interval or to infer one from enrollment.
The record does not list a p-value or an inferential analysis. A p-value, in general, describes how unusual data would be under a specified null model and assumptions; it does not measure the size or importance of an effect. Since the registry reports no primary outcome data or analyses, significance testing cannot answer the feasibility question.
What do the planning assumptions mean?
The registry’s planning description refers to illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial itself used a two-arm randomized design. The registered study is single-group, and allocation is NA.
General: sample-size calculations describe how much information a hypothetical design might need under specified assumptions. They do not demonstrate that a study had a particular probability of finding a result, and they are not observed power. The planning illustrations should not be read as participant counts actually analyzed or as results from the trial. The registry record does not report a trial-specific statistical plan or sample-size justification.
Why does over-dispersion matter in general?
General: over-dispersion occurs when variability in count data exceeds what a chosen model expects. If ignored, standard errors can be too small and intervals or tests can be misleading. This concept is relevant when count outcomes and model-based analyses are used, but the registry does not report such an analysis for this study. No model, dispersion estimate, or analysis of the primary endpoint is reported; therefore, no conclusion about over-dispersion can be made for these results.
Overall, the methods described in the registry define an intended feasibility question, but the reported termination and absence of primary data prevent estimation. The general statistical concepts above explain the role of design, denominators, uncertainty, and planning assumptions without filling in results that the registry does not report.
10. Multiplicity, Missing Data and Analysis Populations
The study planned to assess several questionnaire domains: symptoms, anxiety and depression, pain, and quality of life. The registry names MDASI, HADS, BPI, and FACT-Cx and frames completion at 2 months as the primary outcome. It does not report results for these measures or statistical analyses of them.
Multiplicity arises when several outcomes or statistical tests are considered. General: the more tests performed, the greater the chance that at least one result appears unusual by chance if each is judged separately. Statistical plans sometimes specify a primary outcome, a testing hierarchy, or an adjustment procedure to address this issue. The registry record does not report a multiplicity strategy, hierarchy among the questionnaire measures, or any adjustment. With no primary outcome data and no analyses reported, there are no test results whose multiplicity can be evaluated.
Missing data are central because the registry explicitly states that data were not collected due to early protocol termination. This differs from having collected outcome data and then finding some questionnaires incomplete. The record does not report how many participants completed or missed each instrument, whether any partial assessments exist, or whether missing-data methods were planned or used. It also does not report imputation, sensitivity analyses, or rules for handling incomplete questionnaires.
The analysis population is not described in a statistical analysis plan. The record does not say whether any planned analysis would include all enrolled participants, only those who began treatment, or only those with completed assessments. No inference about an analysis population can be made from enrollment alone. Because the endpoint data were not collected, an observed completion proportion and its denominator are unavailable; the missing result should not be treated as a zero completion rate.
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 |
|---|---|---|---|
| Propranolol + Relaxation/Guided Imagery | 1 | 5 | 20.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Propranolol + Relaxation/Guided Imagery | 1 of 5 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Propranolol + Relaxation/Guided Imagery | 2 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Propranolol + Relaxation/Guided Imagery |
|---|---|---|
| Urine Output decreased | Investigations | 1 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Propranolol + Relaxation/Guided Imagery |
|---|---|---|
| Hypotension | Vascular disorders | 2 of 5 |
| Pain | General disorders | 2 of 5 |
| Edema limbs | General disorders | 1 of 5 |
| Fatigue | General disorders | 1 of 5 |
| Dizziness | Nervous system disorders | 1 of 5 |
| Headache | Nervous system disorders | 1 of 5 |
| Nausea | Gastrointestinal disorders | 1 of 5 |
| Vomiting | Gastrointestinal disorders | 1 of 5 |
| Constipation | Gastrointestinal disorders | 1 of 5 |
| Hyperkalemia | Metabolism and nutrition disorders | 1 of 5 |
Serious events with the highest arm-level rate: urine output decreased (20.0%).
The registry lists safety figures for the propranolol plus relaxation/guided imagery group. It records 5 participants at risk for serious adverse events, with 1 affected, and 5 at risk for other adverse events, with 2 affected. It also lists 1 death. These are the posted counts; the record does not provide enough detail to establish the timing, cause, or relationship of each event to the intervention.
The top serious adverse-event term is decreased urine output, listed as 20.0%. That percentage is reported as a registry value and should not be treated as a comparison with another group: no comparator group is reported. The record does not provide event-level details, severity grades, timing, or an attribution judgment in the information available for this analysis.
General: adverse-event counts describe events recorded under a study’s reporting process. They do not, by themselves, establish that the intervention caused an event or that an event was unrelated. Small safety counts also provide limited precision about how often events might occur in other settings. No comparative safety estimate is available from this single-group record. The listed death should be reported as a registry safety figure, without assigning causality or implying a connection that the registry does not state.
12. What the Result Does, and Does Not, Mean
The result does not provide an answer to the primary feasibility question. Although the study aimed to determine the proportion of patients completing symptom inventories and related questionnaires at 2 months, the registry says those data were not collected because the protocol was terminated early. No completion proportion, treatment completion rate, or patient-reported outcome estimate is reported.
The absence of data is not evidence that participants failed to complete questionnaires, nor is it evidence that the measures were completed successfully. It is also not a finding that propranolol, relaxation, or guided imagery did or did not affect symptoms, anxiety, depression, pain, or quality of life. Those interpretations would require outcome observations that the registry does not report.
The study enrolled 6 participants, but enrollment alone does not reveal how many received the intervention as intended, how many completed questionnaires, or what happened to their scores. The registry’s safety counts provide a separate descriptive account; they do not fill the missing efficacy or feasibility endpoint and do not establish causation.
The single-group design is another boundary on interpretation. Even if changes in questionnaire scores had been reported, there is no randomized comparator in the registry against which to assess what might have happened without the combined intervention. The posted record therefore cannot support a controlled treatment-effect conclusion. The reason for early termination is not reported in the registry record, so it cannot be used to explain the absence of outcomes.
The defensible reading is that the planned primary data were unavailable after early termination. The record documents the study’s aims, design, enrollment, and selected safety figures, but does not report the outcome evidence needed to answer its main feasibility question.
13. Why This Trial Matters Statistically
This study is statistically instructive because it separates a study’s intended question from the evidence it ultimately reports. A clear feasibility endpoint was identified: completion of symptom and related questionnaires at 2 months. Yet the registry states that primary outcome data were not collected following early termination. A planned endpoint is not an observed result, and an enrollment figure cannot substitute for the missing completion data.
The record also illustrates why design details shape interpretation. The study was single group, with no randomized allocation or comparator. Its broader aims included possible effects on symptoms and quality of life, but a single-group design does not offer a like-for-like control comparison. That limitation would matter for causal interpretation even if outcome data were available.
Another statistical lesson is the distinction between missing results and negative results. The registry does not report a low completion rate or no change in symptoms; it reports that primary outcome data were not collected. Treating unavailable data as a measured zero would change the meaning of the evidence.
Finally, the registry’s safety counts and planning assumptions answer different questions from the primary feasibility endpoint. Safety counts are descriptive and do not show causation. Planning illustrations are not observed power or trial results. Keeping these evidence types separate prevents a record with limited outcome reporting from being made to support conclusions it cannot establish.
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 limitation is that the registry reports no primary outcome data because the protocol was terminated early. Thus the planned questionnaire-completion proportion at 2 months cannot be estimated, and no result is available for the broader feasibility aims. The reason for termination is not reported in the registry record.
The study had a single group, no randomized allocation, and no comparator. Any interpretation of possible changes in symptoms or quality of life would therefore lack a like-for-like control comparison. In this record, no such outcome changes are reported in any case.
Although 6 participants were enrolled, the registry does not report how many received each intervention component, completed treatment, completed individual questionnaires, or contributed outcome measurements. It also does not report the analysis population, a completion definition, handling of missing observations, or a detailed statistical analysis plan. These omissions prevent assessment of the endpoint denominator and analytic choices.
Safety reporting is limited to the posted group counts, the listed death, and the top serious adverse-event term. The registry information does not establish event timing, attribution, or a comparison with another group. No additional causal interpretation is warranted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX) — NCT01902966.
- Registry record last updated 2021-10-12; status last verified 2021-09.
- Results first posted 2021-10-12.
- 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
The registry describes a single-group feasibility study of propranolol with relaxation and guided imagery in women with advanced, recurrent, incurable cervical cancer. It lists 6 participants enrolled and a primary endpoint of questionnaire completion at 2 months. There was no randomized comparator, and masking is recorded as none.
The record states that primary outcome data were not collected because the protocol was terminated early. It reports no statistical analyses and no estimate of questionnaire completion or effects on symptoms, anxiety, depression, pain, or quality of life. Safety information includes the group counts and one listed death; the record does not establish causality. The reason for early termination is not reported in the registry record.