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Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy

Head and Neck Carcinoma Clinical Trial

Official title:
A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03602066
Study type Interventional
Source University of Arizona
Contact
Status Terminated
Phase Phase 2
Start date February 14, 2019
Completion date November 7, 2022
View Details
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