NCT07885033Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
A Randomized Pilot Study of the OSEM Oral Side-Effect Management Program in Adults Receiving Head and Neck Radiation Therapy at Premier Cancer Center
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Aug 2027
- Lead sponsor
- UNCANCER LLC
- Diseases
- Head and neck cancer
- NCT number
- NCT07885033
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Nov 2026 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Premier Cancer Center Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.