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

Primary Purpose

Head and Neck Carcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chlorine Dioxide Sterilization
Laboratory Biomarker Analysis
Placebo
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Arizona Medical Center-University Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (chlorine dioxide sterilization)

Arm II (placebo)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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.
Rates of radiotherapy interruption
Will be tabulated and compared using a chi-square test.

Full Information

First Posted
July 17, 2018
Last Updated
June 21, 2023
Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03602066
Brief Title
Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy
Official Title
A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Study terminated by pharmaceutical company
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (chlorine dioxide sterilization)
Arm Type
Experimental
Arm 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.
Arm Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Chlorine Dioxide Sterilization
Other Intervention Name(s)
Chlorine Dioxide
Intervention Description
Given via oral rinse
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given via oral rinse
Primary Outcome Measure Information:
Title
Incidence of severe oral mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale grade 3)
Description
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.
Time Frame
Up to 30 days post radiotherapy
Secondary Outcome Measure Information:
Title
Time to onset of severe OM (>= World Health Organization [WHO] Mucositis Scale grade 3)
Description
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).
Time Frame
Up to 30 days post radiotherapy
Title
Duration of severe OM (>= World Health Organization [WHO] Mucositis Scale grade 3)
Description
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).
Time Frame
Up to 30 days post radiotherapy
Title
Patient reported outcomes as measured by the Oral Mucositis Weekly Questionnaire (OMWQ)
Description
Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.
Time Frame
Up to 30 days post radiotherapy
Title
Rates of radiotherapy interruption
Description
Will be tabulated and compared using a chi-square test.
Time Frame
Up to 30 days post radiotherapy
Other Pre-specified Outcome Measures:
Title
Oral microbiome
Description
Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.
Time Frame
Up to 30 days post radiotherapy
Title
Salivary TNFalpha, IL-1beta, and IL-6 levels
Description
Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.
Time Frame
Up to 30 days post radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Yi
Organizational Affiliation
The University of Arizona Medical Center-University Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona Medical Center-University Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

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

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