Head and Neck CarcinomaPhase 2NCT03602066
Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy
A Phase 2 study testing Chlorine Dioxide Sterilization and Laboratory Biomarker Analysis in people with Head and Neck Carcinoma, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Chlorine Dioxide Sterilization and Laboratory Biomarker Analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 7 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724
About this study
Official title: A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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
- Being tested
- Chlorine Dioxide Sterilization, Laboratory Biomarker Analysis, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorine Dioxide SterilizationDrug
Also called Chlorine Dioxide
Given via oral rinse
Laboratory Biomarker AnalysisOther
Correlative studies
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given via oral rinse
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Laboratory Biomarker Analysis; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days post radiotherapy
Secondary outcomes (4)
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).
Measured: Up to 30 days post radiotherapy
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).
Measured: Up to 30 days post radiotherapy
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.
Measured: Up to 30 days post radiotherapy
Rates of Radiotherapy Interruption
Will be tabulated and compared using a chi-square test.
Measured: Up to 30 days post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start14 Feb 2019
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Why it stopped: Study terminated by pharmaceutical company
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sun Yi, Principal investigator, The University of Arizona Medical Center-University Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602066
- Sponsor's protocol ID
- 1712123818
- Other IDs
- NCI-2018-00214, 1712123818, P30CA023074
- Status last verified
- Feb 2024
- First submitted
- 17 Jul 2018
- Last updated
- 20 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy
- ClinicalTrials.gov ID
- NCT03602066
- Acronym / sponsor ID
- 1712123818
- Conditions
- Head and Neck Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by pharmaceutical company
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 20 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (chlorine dioxide sterilization) | Experimental | Drug: Chlorine Dioxide Sterilization, Other: Laboratory Biomarker AnalysisPatients 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 II (placebo) | Placebo comparator | Other: Laboratory Biomarker Analysis, Other: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorine Dioxide SterilizationAlso: Chlorine DioxideGiven via oral rinse | Drug | Arm I (chlorine dioxide sterilization) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (chlorine dioxide sterilization), Arm II (placebo) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven via oral rinse | Other | Arm II (placebo) |
Primary outcome
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. No grade 3 or higher Oral Mucositis was reported on either treatment arm, so no differences were observed.
4 secondary outcomes
Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)
Time frame: Up to 30 days post radiotherapy
Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)
Time frame: Up to 30 days post radiotherapy
Patient Reported Outcomes as Measured by the Oral Mucositis Weekly Questionnaire (OMWQ)
Time frame: Up to 30 days post radiotherapy
Rates of Radiotherapy Interruption
Time frame: Up to 30 days post radiotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Head and Neck Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Yi principal investigator
The University of Arizona Medical Center-University Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorine Dioxide Sterilization and Laboratory Biomarker Analysis in people with Head and Neck Carcinoma, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3) (time frame: Up to 30 days post radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.