Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors (NCT03612531), a na na study. The primary outcome is Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors.

2. Clinical Question

The MANTLE pilot trial concerns whether participants with fibrosis-related late effect dysphagia after head and neck cancer treatment can complete a manual therapy program. Its primary question is about feasibility: the endpoint is the count of participants who successfully complete the full six weeks of therapy. The registry record describes the therapy and its schedule, but does not report the observed number who completed it. It therefore does not establish a completion rate or show how precisely feasibility was estimated.

The study also lists outcomes concerning response durability, swallowing function and physiology, range of motion, quality of life, symptom burden, fibrosis and lymphedema staging, performance status, and soft tissue fibrosis. These additional domains provide context for what the trial intended to assess, but their presence in the record does not establish that results are available or that any particular change occurred.

3. Trial Design

This is the Pilot MANTLE Trial, registered as NCT03612531 and sponsored by M.D. Anderson Cancer Center. Its phase is listed as NA, allocation is NA, masking is NONE, and the model is SINGLE GROUP. The record lists enrollment of 26 and characterizes the study as active, not recruiting. The start date is 2018-08-06, and the primary completion date is 2022-07-15.

The intervention is a procedure named Manual Therapy. The arm description states that participants receive 10 manual therapy sessions performed by a speech pathologist during weeks 1-6. After completion of 6 weeks of therapy, participants perform manual therapy at home daily for 6 weeks. The registry summary describes massage and stretching exercises involving the neck, throat, jaw, and mouth. These details describe the intervention as recorded; they do not establish how consistently each participant received or performed it.

A single-group design does not provide a separate untreated or alternative-treatment group for a like-for-like comparison. The record explicitly notes that this is not a randomized comparison. Consequently, the trial's primary feasibility endpoint is interpreted as a description of completion within the study group, not as an estimate of a difference between treatment groups. The record does not report a randomization procedure, a masking procedure beyond NONE, or a parallel control regimen.

The record lists 11 outcome measures and 0 analyses. That listing alone does not say which measures have completed data, what analytic procedures were used, or whether results have been entered elsewhere in the registry. The primary endpoint timeframe is 6 weeks of MT. Other outcome domains are named, but their detailed measurement schedules and results are not reported in the registry record. The design and status information should therefore be distinguished from evidence about endpoint outcomes: a registered study description is not, by itself, a report of the study's findings.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors, measured over 6 weeks of MT.

The primary endpoint is titled “Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors.” It is measured in participants and defined as the count of participants successfully completing the full 6 weeks of manual therapy. The timeframe is 6 weeks of MT. This is a binary participant-level outcome in the sense that each participant either meets the stated completion criterion or does not; the registry expresses the primary measure as a count.

A completion count is relevant to feasibility because it describes whether participants can carry out the planned therapy schedule through the specified endpoint. Feasibility is distinct from clinical benefit: completion alone does not establish that swallowing, range of motion, symptoms, or quality of life changed. Nor does it show how the intervention compares with another approach, because the study has a single-group design.

The registry record does not report the observed completion count, the denominator used for the primary endpoint, or a confidence interval for the endpoint. Enrollment is listed as 26, but that figure cannot be assumed to be the number included in the endpoint analysis. Without the endpoint result and analysis population, the completion count cannot be converted into an estimated completion proportion or interpreted for precision. The listed endpoint clarifies what the study set out to assess, but the available record does not provide the result needed to evaluate that assessment.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation starts with identifying the question each measure can answer. The primary endpoint is a count of participants who successfully complete the full 6 weeks of manual therapy. The count is useful as a direct feasibility description, but interpretation also depends on knowing how many participants were eligible for that endpoint and how missing or incomplete observations were handled. The registry record does not report the completion count, endpoint denominator, or missing-data procedure.

What does a participant count tell the reader?

A participant count records how many people meet a stated outcome definition. For a completion endpoint, the outcome definition is completion of the full planned 6 weeks. The count alone does not communicate the fraction of the relevant group that completed treatment. That fraction requires a defined denominator, such as the population assessed for the endpoint, and an explicit rule for participants whose outcome is unknown. The record's enrollment figure is not automatically the denominator, and the safety risk set is not automatically the endpoint denominator.

If a study reports a proportion, its precision can be expressed with a confidence interval. In general, a confidence interval describes uncertainty around an estimate under the assumptions of the statistical method. It does not account automatically for selection bias, incomplete follow-up, or a mismatch between the analyzed population and the target population. No interval or primary endpoint estimate is reported in the registry record, so precision cannot be evaluated for this feasibility outcome.

Why does the design matter?

The trial is listed as SINGLE GROUP, with allocation NA and masking NONE. A one-group study can describe completion, changes over time, or observed events in the enrolled group. It does not supply a concurrent control group against which to estimate a comparative treatment effect. If swallowing or another outcome were measured at more than one time, a within-group change would still not by itself distinguish an intervention effect from natural change, other care, measurement variation, or changes in participant circumstances. The registry record does not report the analysis details needed to assess any such change.

The registry identifies 11 outcome measures and lists 0 analyses. Multiple outcomes can address different aspects of a study, but examining many outcomes raises questions about which are primary, which analyses were planned, and how chance findings are interpreted. The primary endpoint is identified as a feasibility count. The listed secondary domains include response durability, swallowing function and physiology, lingual and jaw range of motion, swallowing-related quality of life, symptom burden, lymphedema and fibrosis staging, performance status, and soft tissue fibrosis. No adjustment method or hierarchy for interpreting these measures is reported in the registry record.

What do the planning illustrations mean?

Any sample-size illustrations should be read as hypothetical planning calculations rather than observed trial results. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. The record explicitly characterizes these as planning illustrations computed from the observed effect, not as the trial's own design. Because this trial is single-group, the equal-allocation, two-arm assumptions do not describe its registered design. Such illustrations are not observed power, do not establish the study's actual power, and do not provide evidence that a treatment effect exists.

Over-dispersion is a general statistical concern when count outcomes vary more than a model assumes. In that setting, a model that assumes less variability may give uncertainty estimates that are too narrow. This general issue is not a claim about the primary endpoint in this study: the endpoint is a participant count, and the registry record does not report a count model, dispersion estimate, or inferential analysis. The endpoint's simple count definition does not, by itself, tell the reader which statistical model was used or whether one was used.

For a binary completion outcome, the analysis must define what counts as completion, the population included, and how unknown outcomes are handled. A confidence interval around a proportion can communicate sampling uncertainty, while a clearly specified analysis population clarifies who contributes to the estimate. These are general principles, not reported methods for this trial. The registry record does not report a statistical analysis plan, a sample-size justification, interim analyses, a missing-data strategy, or the analysis population. Without those details and the observed endpoint result, a reader cannot reproduce the primary analysis or judge its precision.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures and names several secondary domains in addition to the primary feasibility endpoint. Multiple outcomes are often used to capture different dimensions of a clinical question. However, when many outcomes are examined, the chance of seeing an apparently notable result by chance can increase, especially if outcomes or analyses are selected after results are known. This general concern makes it important to know which outcomes and analyses were specified in advance and how the findings are intended to be interpreted.

The registry record does not report a multiplicity adjustment, a hierarchy of secondary outcomes, or an analysis plan that explains how multiple outcomes would be handled. The count of 0 analyses is not evidence about whether any adjustment was applied outside the registry; it only means no analyses are listed in the record information. The named secondary outcome domains should not be treated as evidence of measured effects because their results are not reported.

Missing data are particularly relevant to a completion endpoint: a participant who does not have a documented completion status cannot automatically be classified as either a completer or a non-completer without an explicit rule. The record does not report missing endpoint data, withdrawals, reasons for missingness, imputation, or sensitivity analyses. It also does not report a participant flow description or the population used for primary or secondary analyses. Enrollment of 26 is recorded, but it does not establish the endpoint analysis denominator. The separate safety risk set of 24 likewise does not define the primary analysis population.

These omissions limit assessment of both bias and precision. If people with unknown outcomes differ from those with observed outcomes, a complete-case result could misrepresent the study group. That is a general possibility, not a claim that missingness occurred in this trial. The registry record does not describe how such issues were assessed or addressed.

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.

Most frequent non-serious adverse event terms

The registry safety summary lists 0 serious adverse events among 24 participants at risk, 1 other adverse event among 24 participants at risk, and 0 deaths. These counts should be read according to their separate categories: serious adverse events, other adverse events, and deaths. They are not measures of the primary feasibility endpoint, and the safety group of 24 should not be substituted for the primary endpoint denominator.

A count of 0 serious adverse events means that none are recorded in this registry summary for the stated risk group. It does not establish that the intervention is free of risk, particularly without information about observation time, event definitions, monitoring, completeness of reporting, or the characteristics of the participants. The record does not name any serious adverse event terms. It also does not describe the single other adverse event, so its nature and clinical significance cannot be assessed from the listed count.

The counts alone do not establish whether an event was caused by manual therapy. Attribution, timing, severity details, and the approach to collecting adverse events are not reported in the registry record. The safety figures are therefore descriptive registry entries, not comparative estimates: there is no separate control group to support a comparison of event occurrence. They should be interpreted narrowly as the recorded counts, without inferring either causation or the absence of unrecorded events.

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

The trial's registered primary question is whether participants can complete the full 6 weeks of manual therapy. That is a feasibility question, not a direct test of whether the intervention improves swallowing or another clinical outcome. The registry record describes the intended endpoint but does not report the observed completion count. Consequently, it cannot establish the completion level, its uncertainty, or how many participants contributed to its assessment.

The study is single-group and does not have a randomized comparison. Even if within-group outcome measurements were available, changes over time would not establish that manual therapy caused those changes. Other influences and the natural course of symptoms could also contribute. The record names several clinical and functional outcome domains, but does not report their results. It therefore does not support conclusions about improvement, lack of improvement, or durability of response.

The safety entries report 0 serious adverse events, 1 other adverse event, and 0 deaths among 24 participants at risk. These counts do not establish causal attribution or a comparative safety profile. The other event is not described in the record, and the registry information does not give details that would allow a fuller assessment of surveillance or follow-up.

Enrollment of 26, the active-not-recruiting status, and the primary completion date of 2022-07-15 describe the study record, not its results. Planning illustrations are not observed power and are not a substitute for an outcome estimate with uncertainty. The appropriate reading is limited: the registry records a pilot study of manual therapy and defines a completion-based feasibility endpoint, but the posted information does not give the primary result or enough analysis detail to determine its precision. This distinction separates what the trial set out to measure from what the registry record reports as observed evidence.

13. Why This Trial Matters Statistically

Feasibility is a consequential statistical question for a pilot study because the planned intervention requires a defined course of therapy and subsequent home practice. Knowing whether participants can complete the specified schedule can inform how a larger study might be organized. The MANTLE record makes completion of the full 6 weeks the primary endpoint, giving the feasibility question a concrete definition.

At the same time, a completion count has to be reported with its denominator and a clear account of outcome ascertainment to be interpretable. A count without those details cannot show the proportion completing therapy or the precision of that estimate. In this registry record the observed completion count and endpoint denominator are not reported. This gap illustrates why registry descriptions and outcome reporting serve different purposes: a clearly stated question is not the same as an available result.

The single-group design is also important statistically. It can describe participants' completion and outcomes, but it cannot estimate a randomized contrast against a control group. This limits conclusions about causal effects even if the outcomes were fully reported. The study's broad secondary outcome domains may be useful for characterizing swallowing, function, symptoms, and related measures, but multiple outcomes require a transparent plan for prioritization and interpretation. That plan is not reported in the registry record.

Finally, safety counts are most informative when paired with event definitions, observation procedures, descriptions, and attribution. The registry lists counts but not these contextual details. For biostatisticians and clinical researchers, the record is a useful example of the distinctions among a study's objective, its design, and its reported evidence. Those distinctions prevent feasibility aims, safety counts, and planning calculations from being mistaken for demonstrated treatment 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 limitation for interpreting the trial statistically is that the registry record does not report the observed result for its primary endpoint. It defines successful completion of the full 6 weeks of manual therapy as the outcome, but gives neither the completion count nor the denominator used. Enrollment of 26 cannot fill that gap, and the safety risk group of 24 is not identified as the endpoint population. Without an estimate and its uncertainty, the degree of feasibility observed cannot be assessed.

The study is single-group, with allocation listed as NA and masking as NONE. It therefore has no like-for-like randomized control comparison in the registry design. This constrains causal interpretation of any within-group changes. The registry does not give results for the named secondary outcomes or describe the measurement schedule and analytic methods for them.

The record lists 11 outcome measures and 0 analyses, but does not report multiplicity procedures, missing-data handling, participant flow, analysis populations, a statistical analysis plan, or sample-size justification. The exact consequences of these omissions cannot be determined from the record. The serious adverse event and other adverse event counts are also limited by the lack of event descriptions, attribution, timing, and information about follow-up or ascertainment.

These are limitations of the information reported in the registry record; they do not establish that the trial did not collect data or conduct analyses outside the record. They do mean that readers cannot reconstruct the primary estimate, assess its precision, or judge how robust it is to missing outcomes and analytic choices from the information recorded.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors — NCT03612531.
• Registry record last updated 2026-10-13; status last verified 2026-10.
• Results first posted 2026-07-28.
• 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

NCT03612531 is the Pilot MANTLE Trial, sponsored by M.D. Anderson Cancer Center. It is listed as a single-group study of manual therapy for fibrosis-related late effect dysphagia in head and neck cancer survivors. The record gives enrollment of 26, status active, not recruiting, a start date of 2018-08-06, and a primary completion date of 2022-07-15.

The primary endpoint is a participant count of those successfully completing the full 6 weeks of manual therapy. The observed count and endpoint denominator are not reported in the registry record. The safety summary lists 0 serious adverse events, 1 other adverse event, and 0 deaths among 24 participants at risk. The record lists 11 outcome measures and 0 analyses, but does not report the primary result, analysis population, or statistical plan. These entries describe the registered study and its available registry information, not a comparative estimate of treatment effect.