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

Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03602066
• Other study ID #: 1712123818
• Secondary ID: NCI-2018-0021417
• Status: Terminated
• Phase: Phase 2
• Start date: February 14, 2019
• Est. completion date: November 7, 2022

Study information

• Verified date: February 2024
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 7, 2022
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Mucositis

Intervention

Drug:
• Chlorine Dioxide Sterilization
Given via oral rinse

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Placebo
Given via oral rinse

Locations

Country	Name	City	State
United States	The University of Arizona Medical Center-University Campus	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oral Microbiome	Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.	Up to 30 days post radiotherapy
Other	Salivary TNFalpha, IL-1beta, and IL-6 Levels	Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.	Up to 30 days post radiotherapy
Primary	Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3)	Will be compared between arms. Analysis will be performed by estimating the proportion with exact 95% binomial confidence interval for each group separately. Statistical testing will use a chi-square test. As an alternative, Fisher?s Exact Test will be used if the minimum expected value is < 5.; WHO Scale: Grade 0 (none) - None; Grade I (mild) - Oral soreness, erythema; Grade II (moderate) - Oral erythema, ulcers, solid diet tolerated; Grade III (severe) - Oral ulcers, liquid diet only; Grade IV (life-threatening) - Oral alimentation impossible.; No grade 3 or higher Oral Mucositis was reported on either treatment arm, so no differences were observed.	Up to 30 days post radiotherapy
Secondary	Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)	Will be tabulated and the median week to onset will be computed for each group. Comparison will be performed using a Wilcoxon Rank Sum Test (as the values are unlikely to be normally distributed).	Up to 30 days post radiotherapy
Secondary	Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)	will be tabulated and the median week to onset will be computed for each group. Comparison will be performed using a Wilcoxon Rank Sum Test (as the values are unlikely to be normally distributed).	Up to 30 days post radiotherapy
Secondary	Patient Reported Outcomes as Measured by the Oral Mucositis Weekly Questionnaire (OMWQ)	Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.	Up to 30 days post radiotherapy
Secondary	Rates of Radiotherapy Interruption	Will be tabulated and compared using a chi-square test.	Up to 30 days post radiotherapy