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

NCT ID: NCT03602066

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-14
• Study Completion Date: 2022-11-07

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.

Conditions

Head and Neck Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arm I (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.

Group Type: EXPERIMENTAL

Chlorine Dioxide Sterilization

Intervention Type: DRUG

Given via oral rinse

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Arm II (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.

Group Type: PLACEBO_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Placebo

Intervention Type: OTHER

Given via oral rinse

Interventions

Chlorine Dioxide Sterilization

Given via oral rinse

Intervention Type: DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Placebo

Given via oral rinse

Intervention Type: OTHER

Other Intervention Names

Chlorine Dioxide; placebo therapy; PLCB; sham therapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sun Yi

Role: PRINCIPAL_INVESTIGATOR

The University of Arizona Medical Center-University Campus

Locations

The University of Arizona Medical Center-University Campus

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2018-00214

Identifier Type: REGISTRY

Identifier Source: secondary_id

1712123818

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA023074

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1712123818

Identifier Type: -

Identifier Source: org_study_id