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

• Status: Suspended
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Collaborator: National Cancer Institute (NCI)
• Treatments: Chlorine dioxide

Criteria

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