Head and Neck Cancer (H&N)OSEMNCT07885033
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
A study testing ORAL CARE PRODUCT KIT in people with Head and Neck Cancer (H&N) and Oral Mucositis (Ulcerative) Due to Radiation, run by UNCANCER LLC at 1 site in United States.
Trial summary
People having radiation therapy to the head and neck often develop painful mouth problems - mouth sores, dry mouth, mouth pain, trouble eating and drinking, and changes in taste. These problems can become severe enough to interrupt radiation treatment or lead to an emergency room visit or a hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation, Stomatitis (Oral Mucositis)
- What is being tested?
- ORAL CARE PRODUCT KIT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older Histologically confirmed malignancy of a head and neck site Planned definitive or post-operative external beam radiation therapy to a head and neck site, delivered at Premier Cancer Center Planned course of at least 20 fractions over approximately 4 to 7 weeks With or without concurrent systemic therapy Able to provide written informed consent Able to complete an electronic questionnaire in English, with or without assistance
Who cannot join
- Palliative short-course radiation, or a planned course of fewer than 20 fractions Re-irradiation of a previously irradiated head and neck field Radiation delivered at an institution other than Premier Known allergy or sensitivity to any component of the Peace of Mouth Kit Any condition that, in the judgment of the treating radiation oncologist or the Premier Physician of Record, makes participation unsafe or impracticable Inability to complete study assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Premier Cancer Center
Clearwater, Florida, 33765-1703
OSEM Study Coordinator, 844-806-0124, osem@uncancer.com
About this study
Official title: A Randomized Pilot Study of the OSEM Oral Side-Effect Management Program in Adults Receiving Head and Neck Radiation Therapy at Premier Cancer Center
People having radiation therapy to the head and neck often develop painful mouth problems - mouth sores, dry mouth, mouth pain, trouble eating and drinking, and changes in taste. These problems can become severe enough to interrupt radiation treatment or lead to an emergency room visit or a hospital stay.
This study is testing whether an oral care program called OSEM (Oral Side-Effect Management) reduces how severe those mouth problems become.
Read more
Fifty adults starting radiation to a head and neck site at Premier Cancer Center will take part. Each person will be assigned by chance, like a coin toss, to one of two groups:
One group receives the Peace of Mouth Kit - everyday mouth care products including dry mouth candies, ginger candies for nausea, a mouth rinse, a sensitivity toothpaste, a soft toothbrush and a lip balm - together with a short check-in each week with a member of the Premier team right after their radiation treatment.
The other group receives their usual care at Premier, unchanged.
Everyone in the study fills out the same short questionnaire about their mouth each week during radiation, and once more about four weeks after their last treatment. Everyone continues to see their radiation doctor every week, exactly as they would if they were not in the study.
Taking part lasts about 11 weeks in all.
The items in the kit are everyday consumer mouth care products. They are not medicines of any kind, and the U.S. Food and Drug Administration has not approved them to treat or prevent any disease.
Read the detailed description
BACKGROUND
Oral toxicity is among the most burdensome consequences of head and neck radiation therapy. Mucositis, xerostomia, dysgeusia, mucosal pain and impaired oral intake develop during treatment, peak in the later treatment weeks, and can persist for weeks afterwards. Their consequences are not confined to discomfort: reduced oral intake leads to weight loss and dehydration, pain and mucosal injury lead to unplanned clinic and emergency visits, and severe toxicity can interrupt radiation delivery, which is itself associated with poorer disease control.
The OSEM (Oral Side-Effect Management) program combines a baseline structural risk assessment, a weekly patient-reported outcome instrument, a supportive-care product kit, and structured weekly review by a clinical coordinator with a defined escalation pathway to the treating radiation oncologist. No controlled evidence establishes that the program reduces oral symptom severity. That is the question this study asks.
THE INTERVENTION IS A BUNDLE
The test-arm intervention is delivered as a bundle and this study cannot attribute an observed effect to any single component. That limitation is accepted deliberately: the program is delivered as a bundle in practice, and a study of this size cannot support a factorial design. Component attribution is a question for a subsequent trial.
BLINDING
Participants and site staff cannot be blinded, since a kit is either received or not. Three mitigations apply. The primary endpoint is patient-reported and is collected identically in both arms, on the same schedule and in the same mode. Secondary clinical endpoints are adjudicated by a reviewer blinded to allocation, working from records with allocation redacted. The statistician conducting the primary analysis is blinded to arm identity until the analysis is locked.
BASELINE RISK SCORING
An OSEM Stage 1 baseline risk score is computed for every participant in both arms before the first delivered radiation fraction. It is recorded for research only. It is not returned to the participant or to the treating team in either arm, and it does not inform clinical management.
WHAT IS COMMON TO BOTH ARMS AND WHAT IS NOT
The weekly questionnaire is completed by the participant at Premier, ordinarily on the day of the scheduled radiation oncologist visit, and is identical in both arms. Weekly review by the clinical coordinator, the severity band that review acts on, and the escalation pathway are features of the intervention arm only.
Standard of care is unchanged in both arms, including the weekly radiation oncologist assessment and the after-hours on-call service. Nothing is withheld from control participants, and the kit components and equivalent products remain commercially available to anyone.
STATISTICAL APPROACH
This is a pilot study. The primary analysis compares the standardized area under the weekly oral symptom score curve between arms using analysis of covariance, adjusted for the stratification factor and for the baseline oral symptom score, with the treatment effect reported as an adjusted mean difference with a confidence interval. Where the distribution is materially non-normal, a prespecified rank-based alternative is used and the parametric result reported alongside.
No hypothesis test is prespecified for the binary clinical event endpoints, because the study is not powered for them. They are reported as proportions with exact confidence intervals and risk differences. A principal purpose of the study is to estimate the parameters needed to design an adequately powered confirmatory trial.
LIMITATIONS
Premier Cancer Center is a freestanding radiation oncology practice. Capture of acute care received outside Premier is incomplete, and completeness is reported as a limitation by arm rather than assumed.
In a head and neck cohort, concurrent chemoradiation triggers an automatic high-risk condition in the Stage 1 model, so baseline risk variation is limited by design. No claim about Stage 1 discriminative performance can be made from this study.
- Conditions
- Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation, Stomatitis (Oral Mucositis), Xerostomia Due to Radiotherapy, Radiation Toxicity
- Being tested
- ORAL CARE PRODUCT KIT
- Keywords
- oncology side-effect management pilot study
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis, Ulcer, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORAL CARE PRODUCT KITOther
Also called OC ORAL CARE KIT, PEACE OF MOUTH KIT
A kit of six commercially available consumer oral care products, supplied at enrollment, at approximately week 5, and at the final treatment visit in week 7 - three kits in total, each a one-month supply.
Each kit contains: dry mouth candies, 6 packs, xylitol-based, 3 lemon and 3 sour cherry; nausea candies, 1 pack, ginger, xylitol-based; soothing mouth rinse, 30 single-dose stick packs of sodium chloride and sodium bicarbonate, one per day; sensitivity toothpaste with 10% nano-hydroxyapatite and xylitol, 3 oz; a soft bamboo-handled toothbrush; and a lip balm. A reusable bottle for preparing the daily rinse comes with the first kit only.
Use is at the participant's discretion, following written instructions in each kit. Participants may stop any component at any time and are told to do so if it causes discomfort.
No component is a prescription or over-the-counter drug, and none is FDA-approved to treat or prevent any disease.
| Study group | Role | What they receive |
|---|---|---|
| OSEM Program | Experimental | Participants receive the Peace of Mouth Kit at enrollment, at approximately week 5, and at the final treatment visit in week 7 - three kits in total - together with a structured review by the Premier clinical coordinator each week, immediately after radiation treatment.
The weekly review consists of a fixed set of safety-flag questions, review of the participant's weekly symptom band and red-flag status, and assessment of kit use. Where the band or a red-flag criterion indicates it, the coordinator escalates directly to the on-call Premier radiation oncologist, who determines clinical management. The study does not direct clinical management.
Premier standard of care continues unchanged, including the weekly radiation oncologist assessment and the after-hours on-call service. Receives: Other: ORAL CARE PRODUCT KIT |
| STANDARD OF CARE | No intervention | Participants receive Premier standard of care without modification, including the weekly radiation oncologist assessment, the after-hours on-call service, and any supportive-care measure the treating team judges appropriate. Participants complete the same baseline and weekly symptom questionnaire as the intervention arm, for research purposes only. The resulting symptom band is computed and retained for analysis but is not reviewed for escalation, is not returned to anyone, and does not generate any contact. There is no kit, no clinical coordinator review and no safety-flag questions. Kit components and equivalent products remain commercially available, and nothing is withheld from participants in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral symptom burden: area under the weekly oral symptom score curve
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.
Measured: 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.
Secondary outcomes (8)
Peak oral symptom severity
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.
Measured: From Time 0 through the end-of-treatment assessment, up to 7 weeks and then a final follow up 4 weeks later
Time to first moderate or worse oral symptom
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.
Measured: From Time 0 through the end-of-treatment assessment, up to 7 weeks and then a final follow up 4 weeks later
Proportion of participants reaching severe or very severe oral symptom severity
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.
Measured: From Time 0 through the end-of-treatment assessment, up to 7 weeks and then a final follow up 4 weeks later
Unplanned acute-care use attributable to oral toxicity
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.
Measured: From Time 0 through the follow-up assessment 4 weeks after the final radiation fraction, up to 11 weeks
Unplanned radiation treatment interruption attributable to oral toxicity
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.
Measured: From Time 0 through the final radiation fraction, up to 7 weeks
Enteral or parenteral nutrition escalation attributable to oral toxicity
Number of participants with new or escalated enteral or parenteral nutrition support attributable to oral toxicity, adjudicated by a reviewer blinded to arm allocation.
Measured: From Time 0 through the follow-up assessment 4 weeks after the final radiation fraction, up to 11 weeks
Change in body weight
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.
Measured: Baseline, end of treatment (up to 7 weeks), and follow-up 4 weeks after the final radiation fraction (up to 11 weeks)
Oral symptom burden at the follow-up assessment
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.
Measured: Follow-up assessment 4 weeks after the final radiation fraction, up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&N)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNCANCER LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PREMIER CANCER CENTER
- Responsible party
- Sponsor
- Investigators
- ABIDA TAHER, Principal investigator, UNCANCER LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885033
- Sponsor's protocol ID
- OSEM-PREMIER-PROSP-01
- Acronym
- OSEM
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data supporting the published results will be made available, together with the Statistical Analysis Plan and the analysis code. The frozen OSEM model specification, build identifier and cryptographic hashes are also made available, so that any published score can be independently reconstructed.