Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT03602066
Brief Summary:
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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate and compare CloSYS Unflavored Oral Rinse effect on the incidence of severe oral 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).
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.
Study:
NCT03602066
Study Brief:
Protocol Section:
NCT03602066