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

Phase 2

Terminated

Interventions: Drug: Chlorine Dioxide Sterilization
Other: Laboratory Biomarker Analysis
Other: Placebo

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm I (chlorine dioxide sterilization)	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.
Arm II (placebo)	Laboratory Biomarker Analysis	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.
Arm II (placebo)	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.
Arm I (chlorine dioxide sterilization)	Laboratory Biomarker Analysis	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3)	Up to 30 days post radiotherapy	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)	Up to 30 days post radiotherapy	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).
Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)	Up to 30 days post radiotherapy	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).
Patient Reported Outcomes as Measured by the Oral Mucositis Weekly Questionnaire (OMWQ)	Up to 30 days post radiotherapy	Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.
Rates of Radiotherapy Interruption	Up to 30 days post radiotherapy	Will be tabulated and compared using a chi-square test.