Trial · NCT07885033
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
NCT07885033, Not applicable, Not yet recruiting, UNCANCER LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy. Trials, record NCT07885033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07885033
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
- NCT number
- NCT07885033
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 50 participants, estimated
- Lead sponsor
- UNCANCER LLC
- Conditions
- Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation, Stomatitis (Oral Mucositis), Xerostomia Due to Radiotherapy, Radiation Toxicity
- Interventions
- ORAL CARE PRODUCT KIT
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07885033
GET https://conductscience.org/api/trials/v1/NCT07885033/registered