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

NCT03602066 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 1712123818NCI-2018-00214P30CA023074
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)

  Up to 30 days post radiotherapy

• Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)

  Up to 30 days post radiotherapy

• Patient Reported Outcomes as Measured by the Oral Mucositis Weekly Questionnaire (OMWQ)

  Up to 30 days post radiotherapy

• Rates of Radiotherapy Interruption

  Up to 30 days post radiotherapy

Other Outcomes (2)

• Oral Microbiome

  Up to 30 days post radiotherapy

• Salivary TNFalpha, IL-1beta, and IL-6 Levels

  Up to 30 days post radiotherapy

Study Arms (2)

Arm I (chlorine dioxide sterilization)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis

Arm II (placebo)

PLACEBO COMPARATOR

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; Other: Placebo

Interventions

Chlorine Dioxide Sterilization DRUG

Given via oral rinse

Also known as: Chlorine Dioxide

Arm I (chlorine dioxide sterilization)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (chlorine dioxide sterilization); Arm II (placebo)

Placebo OTHER

Given via oral rinse

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Arizona Medical Center-University Campus

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Interventions

chlorine dioxide

Limitations and Caveats

This study stopped accrual early as the IP manufacturer terminated the study stopping funding and IP. 14 out of 20 subjects were accrued, 11 of which completed study. Due to early termination with few patients, only the counts of events have been calculated and no testing was done.

Results Point of Contact

• Title: Jared Robbins, MD
• Organization: University of Arizona Cancer Center

jrobbins@arizona.edu

520-626-6724

Study Officials

• Sun Yi

  The University of Arizona Medical Center-University Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: February 14, 2019
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: March 20, 2024
• Results First Posted: March 20, 2024

Record last verified: 2024-02

Locations

US (1)