Ignite Creation Date:
2025-12-17 @ 3:12 PM
Ignite Modification Date:
2025-12-23 @ 11:16 PM
Study NCT ID:
NCT03602066
Status:
TERMINATED
Last Update Posted:
2024-03-20
First Post:
2018-07-17
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated by pharmaceutical company
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1712123818 | OTHER | The University of Arizona Medical Center-University Campus | View | |
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2018-00214 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |