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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03602066
Recruitment Status : Suspended (per Pharma company)
First Posted : July 26, 2018
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

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.

Condition or disease Intervention/treatment Phase
Head and Neck Carcinoma Drug: Chlorine Dioxide Sterilization Other: Laboratory Biomarker Analysis Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Chlorine Dioxide Sterilization
Given via oral rinse
Other Name: Chlorine Dioxide

Other: Laboratory Biomarker Analysis
Correlative studies

Placebo Comparator: 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.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Placebo
Given via oral rinse
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy




Primary Outcome Measures :
  1. Incidence of severe oral mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale grade 3) [ Time Frame: Up to 30 days post radiotherapy ]

    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 :
  1. Time to onset of severe OM (>= World Health Organization [WHO] Mucositis Scale grade 3) [ Time Frame: Up to 30 days post radiotherapy ]
    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).

  2. Duration of severe OM (>= World Health Organization [WHO] Mucositis Scale grade 3) [ Time Frame: Up to 30 days post radiotherapy ]
    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).

  3. Patient reported outcomes as measured by the Oral Mucositis Weekly Questionnaire (OMWQ) [ Time Frame: Up to 30 days post radiotherapy ]
    Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.

  4. Rates of radiotherapy interruption [ Time Frame: Up to 30 days post radiotherapy ]
    Will be tabulated and compared using a chi-square test.


Other Outcome Measures:
  1. Oral microbiome [ Time Frame: Up to 30 days post radiotherapy ]
    Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.

  2. Salivary TNFalpha, IL-1beta, and IL-6 levels [ Time Frame: Up to 30 days post radiotherapy ]
    Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602066


Locations
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United States, Arizona
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sun Yi The University of Arizona Medical Center-University Campus
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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03602066    
Other Study ID Numbers: 1712123818
NCI-2018-00214 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1712123818 ( Other Identifier: The University of Arizona Medical Center-University Campus )
P30CA023074 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorine dioxide
Dental Disinfectants
Disinfectants
Anti-Infective Agents