Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

ORAL CARE PRODUCT 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 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.

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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)