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

University of Arizona

Status and phase: Terminated; Phase 2

Conditions: Head and Neck Carcinoma

Treatments: Other: Placebo; Other: Laboratory Biomarker Analysis; Drug: Chlorine Dioxide Sterilization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03602066

NCI-2018-00214 (Registry Identifier)

P30CA023074 (U.S. NIH Grant/Contract)

1712123818 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups, including a placebo group

Arm I (chlorine dioxide sterilization)

Experimental group

Description:

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.

Treatment:

Drug: Chlorine Dioxide Sterilization

Other: Laboratory Biomarker Analysis

Arm II (placebo)

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Other: Laboratory Biomarker Analysis