UNCANCER LLC
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.
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 Managem…
Inclusion Criteria: 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 Exclusion Criteria: Palliative short-course radiation, or a planned course of fewer than 20 fractions Re-irradiation…
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.