Oral Care Program for Head and Neck Cancer

(OSEM Trial)

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.