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

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 Overview

• Status: Terminated
• Conditions: Head and Neck Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Drug: Chlorine Dioxide Sterilization; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Medical Center-University Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to provide properly obtained written informed consent
• Pathologically-confirmed diagnosis of head and neck malignancy (stage I-IV)
• Planned to receive high dose RT >= 50 gray (Gy) to visualizable oral cavity and/or oropharyngeal mucosa, with or without administration of concurrent systemic therapy
• Karnofsky performance status of >= 60, within 45 days of registration
• Hematocrit (Hct) > 20 within 90 days of registration to the study
• Normal cognition and willingness to complete OMWQ and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTAE) forms at each designated time point along with oral rinse diary
• Life expectancy >= 3 months
• Willing to tolerate oral rinsing for 30 second intervals
• Negative serum pregnancy test in females of childbearing age
• Must be willing to use an effective form of birth control if of child bearing potential

Exclusion Criteria:

• Known hypersensitivity to chlorine dioxide products
• Chlorine dioxide product usage within the past 7 days prior to registration for this study
• Utilization of any antibiotic medications (topical or systemic) within past 7 days prior to registration for this study
• Utilization of daily anti-inflammatory or corticosteroid medication (topical or systemic) for chronic indication other than daily low dose aspirin (81 mg)
• Sjogrens disease
• Medically documented glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Baseline hematocrit =< 20%
• Planned daily RT of less than 5 weeks duration
• Known history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
• Current pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (chlorine dioxide sterilization); Patients receive chlorine dioxide sterilization oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.	Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Chlorine Dioxide Sterilization; Given via oral rinse; Other Names: Chlorine Dioxide
Placebo Comparator: Arm II (placebo); 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Placebo; Given via oral rinse; Other Names: placebo therapy; PLCB; sham therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3)	Will be compared between arms. Analysis will be performed by estimating the proportion with exact 95% binomial confidence interval for each group separately. Statistical testing will use a chi-square test. As an alternative, Fisher?s Exact Test will be used if the minimum expected value is < 5. WHO Scale: Grade 0 (none) - None; Grade I (mild) - Oral soreness, erythema; Grade II (moderate) - Oral erythema, ulcers, solid diet tolerated; Grade III (severe) - Oral ulcers, liquid diet only; Grade IV (life-threatening) - Oral alimentation impossible. No grade 3 or higher Oral Mucositis was reported on either treatment arm, so no differences were observed.	Up to 30 days post radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)	Will be tabulated and the median week to onset will be computed for each group. Comparison will be performed using a Wilcoxon Rank Sum Test (as the values are unlikely to be normally distributed).	Up to 30 days post radiotherapy
Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)	will be tabulated and the median week to onset will be computed for each group. Comparison will be performed using a Wilcoxon Rank Sum Test (as the values are unlikely to be normally distributed).	Up to 30 days post radiotherapy
Patient Reported Outcomes as Measured by the Oral Mucositis Weekly Questionnaire (OMWQ)	Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.	Up to 30 days post radiotherapy
Rates of Radiotherapy Interruption	Will be tabulated and compared using a chi-square test.	Up to 30 days post radiotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Microbiome	Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.	Up to 30 days post radiotherapy
Salivary TNFalpha, IL-1beta, and IL-6 Levels	Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.	Up to 30 days post radiotherapy

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sun Yi, The University of Arizona Medical Center-University Campus

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): November 7, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Anti-Infective Agents; Disinfectants; Dental Disinfectants; Chlorine dioxide
• Other Study ID Numbers: 1712123818 (Other Identifier: The University of Arizona Medical Center-University Campus); P30CA023074 (U.S. NIH Grant/Contract); NCI-2018-00214 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No