NCT03602066

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
DRUG	Chlorine Dioxide Sterilization	Given via oral rinse
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo	Given via oral rinse

Timeline

• Start date: 2019-02-14
• Primary completion: 2022-11-07
• Completion: 2022-11-07
• First posted: 2018-07-26
• Last updated: 2024-03-20
• Results posted: 2024-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study