Trial · NCT03602066
Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy
NCT03602066, Phase 2, Terminated, University of Arizona; results first posted 2024-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy. Trials, record NCT03602066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03602066
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy
- NCT number
- NCT03602066
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- University of Arizona
- Conditions
- Head and Neck Carcinoma
- Interventions
- Chlorine Dioxide Sterilization, Laboratory Biomarker Analysis, Placebo
- First posted
- 2018-07-26
- Last updated
- 2024-03-20
- Results first posted
- 2024-03-20
- 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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3) | 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. |
| Secondary | Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3) | 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). |
| Secondary | Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3) | 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). |
| Secondary | Patient Reported Outcomes as Measured by the Oral Mucositis Weekly Questionnaire (OMWQ) | 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. |
| Secondary | Rates of Radiotherapy Interruption | Up to 30 days post radiotherapy | Will be tabulated and compared using a chi-square test. |
| Other | Oral Microbiome | 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. |
| Other | Salivary TNFalpha, IL-1beta, and IL-6 Levels | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Up to 30 days post radiotherapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Up to 30 days post radiotherapy | weeks | MEDIAN | |
| SECONDARY | Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Up to 30 days post radiotherapy | weeks | MEDIAN | |
| SECONDARY | Patient Reported Outcomes as Measured by the Oral Mucositis Weekly Questionnaire (OMWQ) | Up to 30 days post radiotherapy | Due to the limited patient numbers this was not assessed. | ||
| SECONDARY | Rates of Radiotherapy Interruption | Up to 30 days post radiotherapy | 3 in Arm II did not complete treatment and were not evaluated for treatment interruption | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Oral Microbiome | Up to 30 days post radiotherapy | This analysis was not performed due to lack of sufficient sample size. | ||
| OTHER_PRE_SPECIFIED | Salivary TNFalpha, IL-1beta, and IL-6 Levels | Up to 30 days post radiotherapy | Analysis not performed due to lack of sufficient patient samples. |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Arm I (Chlorine Dioxide Sterilization) | 0 | Participants | ||
| Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Arm II (Placebo) | 0 | Participants | ||
| Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Arm I (Chlorine Dioxide Sterilization) | 0 | Full Range 0 to 0 | weeks | |
| Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Arm II (Placebo) | 0 | Full Range 0 to 0 | weeks | |
| Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Arm I (Chlorine Dioxide Sterilization) | 0 | Full Range 0 to 0 | weeks | |
| Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Arm II (Placebo) | 0 | Full Range 0 to 0 | weeks | |
| Rates of Radiotherapy Interruption | Arm I (Chlorine Dioxide Sterilization) | 0 | Participants | ||
| Rates of Radiotherapy Interruption | Arm II (Placebo) | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm II (Placebo) | 8 | |
| Overall Study | STARTED | Arm I (Chlorine Dioxide Sterilization) | 6 | |
| Overall Study | COMPLETED | Arm II (Placebo) | 5 | |
| Overall Study | COMPLETED | Arm I (Chlorine Dioxide Sterilization) | 6 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo) | 3 | |
| Overall Study | NOT COMPLETED | Arm I (Chlorine Dioxide Sterilization) | 0 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Generalized weakness | General disorders | Arm I (Chlorine Dioxide Sterilization) | 5 | 6 | 5 |
| other | Generalized weakness | General disorders | Arm II (Placebo) | 6 | 8 | 6 |
| other | Weight loss | Investigations | Arm I (Chlorine Dioxide Sterilization) | 6 | 6 | 6 |
| other | Weight loss | Investigations | Arm II (Placebo) | 5 | 8 | 5 |
| other | Dry mouth | Gastrointestinal disorders | Arm I (Chlorine Dioxide Sterilization) | 6 | 6 | 6 |
| other | Dry mouth | Gastrointestinal disorders | Arm II (Placebo) | 7 | 8 | 7 |
| other | Sore throat | Respiratory, thoracic and mediastinal disorders | Arm I (Chlorine Dioxide Sterilization) | 6 | 6 | 6 |
| other | Sore throat | Respiratory, thoracic and mediastinal disorders | Arm II (Placebo) | 6 | 8 | 6 |
| other | Dysphagia | Gastrointestinal disorders | Arm I (Chlorine Dioxide Sterilization) | 4 | 6 | 4 |
| other | Dysphagia | Gastrointestinal disorders | Arm II (Placebo) | 6 | 8 | 6 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Chlorine Dioxide Sterilization) | 0 | 6 |
| Total, all-cause mortality | Arm II (Placebo) | 0 | 8 |
| Total, other adverse events | Arm I (Chlorine Dioxide Sterilization) | 6 | 6 |
| Total, other adverse events | Arm II (Placebo) | 8 | 8 |
| Total, serious adverse events | Arm I (Chlorine Dioxide Sterilization) | 0 | 6 |
| Total, serious adverse events | Arm II (Placebo) | 1 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA023074 | University of Arizona Cancer Center - Cancer Center Support Grant | THEODORESCU, DAN | UNIVERSITY OF ARIZONA | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Chlorine Dioxide Sterilization) vs Arm II (Placebo): Rates of Radiotherapy Interruption | Trial comparisons |
| Arm I (Chlorine Dioxide Sterilization) vs Arm II (Placebo): Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3) | Trial comparisons |
| Arm I (Chlorine Dioxide Sterilization) vs Arm II (Placebo): deaths from any cause | Trial comparisons |
| Arm I (Chlorine Dioxide Sterilization) vs Arm II (Placebo): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03602066
GET https://conductscience.org/api/trials/v1/NCT03602066/events?page=2