Clinical trial · Interventional
Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy
A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy
NCT03602066CI-TRIAL-00075221terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated by pharmaceutical company
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorine Dioxide Sterilization | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (chlorine dioxide sterilization)
- 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.
- interventionNames
- Drug: Chlorine Dioxide Sterilization
- Other: Laboratory Biomarker Analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.