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

1712123818

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.

2019-02-14

2022-11-07

2022-11-07

Terminated

Early phase I

14

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}

2024-03-20