Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Oral symptom burden: area under the weekly oral symptom score curve	From the first delivered radiation fraction (Time 0) through the end-of-treatment assessment, up to 7 weeks and the a 4 week end of trial follow up.	The weekly oral symptom score is the sum of eight patient-reported oral symptom domains - mouth pain, mouth sores, dry mouth, dry or chapped lips, taste changes, trouble eating or drinking, nausea when eating or drinking, and dizziness or dark urine - each graded on a four-level scored severity collapse. The score ranges from 0 to 42, where a higher score indicates greater symptom burden. Area under the curve is computed by the trapezoidal rule across available weekly assessments and standardized for the number of assessments contributed, so that participants with different course lengths are comparable. A lower area under the curve indicates lower symptom burden across the radiation course.
Secondary	Peak oral symptom severity	From Time 0 through the end-of-treatment assessment, up to 7 weeks and then a final follow up 4 weeks later	The highest weekly oral symptom score recorded during the radiation course, on the same 0 to 42 scale as the primary outcome measure, where a higher score indicates greater symptom burden.
Secondary	Time to first moderate or worse oral symptom	From Time 0 through the end-of-treatment assessment, up to 7 weeks and then a final follow up 4 weeks later	Time from the first delivered radiation fraction to the first weekly assessment at which any of the eight scored oral symptom domains is recorded at moderate severity or worse.
Secondary	Proportion of participants reaching severe or very severe oral symptom severity	From Time 0 through the end-of-treatment assessment, up to 7 weeks and then a final follow up 4 weeks later	The proportion of participants in whom any of the eight scored oral symptom domains is recorded at severe or very severe at any weekly assessment.
Secondary	Unplanned acute-care use attributable to oral toxicity	From Time 0 through the follow-up assessment 4 weeks after the final radiation fraction, up to 11 weeks	Number of participants with at least one emergency department or urgent care evaluation, or hospitalization, attributable to oral toxicity, impaired oral intake or associated dehydration. Events are ascertained from the Premier medical record and adjudicated by a reviewer blinded to arm allocation. Capture of care received outside Premier is incomplete, and completeness is reported by arm.
Secondary	Unplanned radiation treatment interruption attributable to oral toxicity	From Time 0 through the final radiation fraction, up to 7 weeks	Number of participants with at least one unplanned interruption of radiation delivery attributable to oral toxicity. Occurrence is confirmed from the radiation delivery record and cause from the treating clinician's documentation, adjudicated by a reviewer blinded to arm allocation.
Secondary	Enteral or parenteral nutrition escalation attributable to oral toxicity	From Time 0 through the follow-up assessment 4 weeks after the final radiation fraction, up to 11 weeks	Number of participants with new or escalated enteral or parenteral nutrition support attributable to oral toxicity, adjudicated by a reviewer blinded to arm allocation.
Secondary	Change in body weight	Baseline, end of treatment (up to 7 weeks), and follow-up 4 weeks after the final radiation fraction (up to 11 weeks)	Change in measured body weight from the enrollment baseline to the end-of-treatment assessment, and from the enrollment baseline to the follow-up assessment. Reported in kilograms and as a percentage of baseline weight.
Secondary	Oral symptom burden at the follow-up assessment	Follow-up assessment 4 weeks after the final radiation fraction, up to 11 weeks	The weekly oral symptom score recorded at the follow-up assessment, on the same 0 to 42 scale as the primary outcome measure, where a higher score indicates greater symptom burden.
Other	ePRO completion rate	From Time 0 through the follow-up assessment, up to 11 weeks	The proportion of scheduled ePRO assessments that were submitted, out of the number expected. An assessment is expected at enrollment, in each week a participant is on treatment, and once at the follow-up visit. No item may be skipped, so a submitted assessment is complete by construction: this measure counts whole assessments submitted, not items answered. A missed assessment is recorded with the reason where known. Reported as a percentage, overall and by week, for each arm. A higher percentage indicates more complete data capture. This measure applies to both arms. The instrument, the schedule and the mode of administration are identical in each.
Other	Clinical coordinator weekly review completion rate	From Time 0 through the final radiation fraction, up to 7 weeks	The proportion of scheduled weekly clinical coordinator reviews that were completed and documented, out of the number expected. A review is expected in each week a participant is on treatment. A review counts as completed when the six safety-flag questions have been asked, the band and red-flag status reviewed, kit use assessed, and the review recorded. Reviews not completed are recorded as missed, together with the reason. Reported overall and by week, as a percentage. A higher percentage indicates that the weekly review ran as specified. This measure applies to the OSEM Program arm only. The Standard of Care arm receives no clinical coordinator review.
Other	Time from Stage 2 band review to escalation contact	From Time 0 through the final radiation fraction, up to 7 weeks	Time elapsed from the clinical coordinator's completion of the weekly Stage 2 band and red-flag review to the first documented contact with the on-call Premier radiation oncologist, measured in hours. Both time points are recorded in the study escalation log at the time they occur. The measure is evaluated only for reviews at which the band or a confirmed red-flag criterion indicated escalation. This measure applies to the OSEM Program arm only. No band review and no escalation pathway operate in the Standard of Care arm, so no value exists for that arm and none is reported. A shorter time indicates faster escalation. The measure is reported descriptively, as a feasibility measure of whether the escalation pathway operates as specified. It is not a comparison between arms.
Other	Participant-reported kit use	From Time 0 through the final radiation fraction, up to 7 weeks	Participant self-report of how often each kit component was used in the preceding 7 days, collected on the weekly ePRO. Each of the six components - soothing mouth rinse, sensitivity toothpaste, dry mouth candies, nausea candies, soft toothbrush and lip balm - is answered on a four-level scale: Not at all, A few times, Most days, Every day. The item is not scored and does not contribute to the oral symptom score or the severity band. This measure applies to the OSEM Program arm only, since the Standard of Care arm receives no kit. Reported descriptively as the distribution of responses by component and by week. A higher proportion answering Most days or Every day indicates greater adherence.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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