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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Carcinoma

Intervention / Treatment
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* Drug: Chlorine Dioxide Sterilization
* Other: Laboratory Biomarker Analysis
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (chlorine dioxide sterilization)<br>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. | Drug: Chlorine Dioxide Sterilization<br>* Given via oral rinse<br>* Other names: Chlorine Dioxide;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|
| Placebo Comparator: Arm II (placebo)<br>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<br>* Correlative studies<br>Other: Placebo<br>* Given via oral rinse<br>* Other names: sham therapy;|

What is the study measuring?
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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. | 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 |