This pilot randomized phase II trial studies who well chlorine dioxide sterilization works in reducing oral mucositis in patients with stage I-IV head and neck cancer who are undergoing radiotherapy. Chlorine dioxide sterilization may help to treat oral mucositis.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03602066.
PRIMARY OBJECTIVE:
I. To evaluate and compare CloSYS Unflavored Oral Rinse effect on the incidence of severe oral mucositis (OM) (>= World Health Organization [WHO] grade 3).
SECONDARY OBJECTIVES:
I. To evaluate and compare CloSYS Unflavored Oral Rinse effect on the time to onset of severe OM (>= WHO grade 3).
II. To evaluate and compare CloSYS Unflavored Oral Rinse effect on the duration of severe OM (>= WHO grade 3).
III. To evaluate and compare CloSYS Unflavored Oral Rinse effect in patient reported outcomes as measured by the Oral Mucositis Weekly Questionnaire (OMWQ) and Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
IV. To evaluate and compare CloSYS Unflavored Oral Rinse effect on rates of radiation therapy (RT) interruption.
V. To evaluate and compare CloSYS Unflavored Oral Rinse effect on the oral microbiome.
VI. To evaluate and compare CloSYS Unflavored Oral Rinse effect on salivary TNFalpha, IL-1beta, and IL-6 levels.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients receive chlorine dioxide sterilization oral rinse over 30 seconds twice daily (BID) from the start of radiation therapy (RT) to the evening prior to the 1 month RT follow-up appointment.
ARM II: Patients receive placebo oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.
After completion of study, patients are followed up on day 1.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorJared Rex Robbins
