Trial Outcomes & Findings for Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy (NCT NCT03602066)

NCT ID: NCT03602066

Last Updated: 2024-03-20

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: Up to 30 days post radiotherapy
• Results posted on: 2024-03-20

Participant Flow

The study opened on 02/14/2019 and 8 subjects were accrued between February 2019 and November 2019. A subject discovered mold in the IP and all IP was returned to manufacturer and the 8 subjects were withdrawn from study. The study closed to accrual and re-opened 01/15/2022. Subjects were recruited from the University of Arizona Cancer Center clinic from 01/15/2022-08/24/2022. The study closed prematurely as the drug manufacturer pulled funding and IP. Enrolled = 14

Participant milestones

Measure	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. Laboratory Biomarker Analysis: Correlative studies Placebo: Given via oral rinse	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. Chlorine Dioxide Sterilization: Given via oral rinse Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	8	6
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	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. Laboratory Biomarker Analysis: Correlative studies Placebo: Given via oral rinse	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. Chlorine Dioxide Sterilization: Given via oral rinse Laboratory Biomarker Analysis: Correlative studies
Overall Study Withdrawal by Subject	2	0
Overall Study Physician Decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm I (Chlorine Dioxide Sterilization) n=6 Participants 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. Chlorine Dioxide Sterilization: Given via oral rinse Laboratory Biomarker Analysis: Correlative studies	Arm II (Placebo) n=8 Participants 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. Laboratory Biomarker Analysis: Correlative studies Placebo: Given via oral rinse	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	61.5 years n=5 Participants	64 years n=7 Participants	61.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants
HNC staging Stage I	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
HNC staging Stage II	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
HNC staging Stage III	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
HNC staging Stage IV	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Karnofsky Performance Score	90 Score on a scale n=5 Participants	90 Score on a scale n=7 Participants	90 Score on a scale n=5 Participants
Number of teeth	22 teeth n=5 Participants	28.5 teeth n=7 Participants	25 teeth n=5 Participants
General dental condition Fair	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
General dental condition Good	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
General dental condition Excellent	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Oral Mucositis (OM) Grade 0 (none)	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Oral Mucositis (OM) Grade 1 (mild)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Oral Mucositis (OM) Grade 2 (moderate)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Oral Mucositis (OM) Grade 3 (severe)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Oral Mucositis (OM) Grade 4 (life-threatening)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Oral Mucositis (OM) Grade Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm I (Chlorine Dioxide Sterilization) n=6 Participants 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. Chlorine Dioxide Sterilization: Given via oral rinse	Arm II (Placebo) n=8 Participants 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. Placebo: Given via oral rinse
Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Arm I (Chlorine Dioxide Sterilization) n=6 Participants 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. Chlorine Dioxide Sterilization: Given via oral rinse	Arm II (Placebo) n=8 Participants 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. Placebo: Given via oral rinse
Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)	0 weeks Interval 0.0 to 0.0	0 weeks Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Arm I (Chlorine Dioxide Sterilization) n=6 Participants 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. Chlorine Dioxide Sterilization: Given via oral rinse	Arm II (Placebo) n=8 Participants 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. Placebo: Given via oral rinse
Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)	0 weeks Interval 0.0 to 0.0	0 weeks Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 30 days post radiotherapy

Population: Due to the limited patient numbers this was not assessed.

Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days post radiotherapy

Population: 3 in Arm II did not complete treatment and were not evaluated for treatment interruption

Will be tabulated and compared using a chi-square test.

Outcome measures

Measure	Arm I (Chlorine Dioxide Sterilization) n=6 Participants 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. Chlorine Dioxide Sterilization: Given via oral rinse	Arm II (Placebo) n=5 Participants 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. Placebo: Given via oral rinse
Rates of Radiotherapy Interruption	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days post radiotherapy

Population: This analysis was not performed due to lack of sufficient sample size.

Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days post radiotherapy

Population: Analysis not performed due to lack of sufficient patient samples.

Will be compared between groups using a linear mixed-effects model to account for the correlation among the measurements within an individual.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Chlorine Dioxide Sterilization)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm II (Placebo)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Chlorine Dioxide Sterilization) n=6 participants at risk 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. Chlorine Dioxide Sterilization: Given via oral rinse Laboratory Biomarker Analysis: Correlative studies	Arm II (Placebo) n=8 participants at risk 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. Laboratory Biomarker Analysis: Correlative studies Placebo: Given via oral rinse
Gastrointestinal disorders Dysphagia	0.00% 0/6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	12.5% 1/8 • Number of events 1 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.

Other adverse events

Measure	Arm I (Chlorine Dioxide Sterilization) n=6 participants at risk 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. Chlorine Dioxide Sterilization: Given via oral rinse Laboratory Biomarker Analysis: Correlative studies	Arm II (Placebo) n=8 participants at risk 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. Laboratory Biomarker Analysis: Correlative studies Placebo: Given via oral rinse
General disorders Generalized weakness	83.3% 5/6 • Number of events 5 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	75.0% 6/8 • Number of events 6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
Investigations Weight loss	100.0% 6/6 • Number of events 6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	62.5% 5/8 • Number of events 5 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
Gastrointestinal disorders Dry mouth	100.0% 6/6 • Number of events 6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	87.5% 7/8 • Number of events 7 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
Respiratory, thoracic and mediastinal disorders Sore throat	100.0% 6/6 • Number of events 6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	75.0% 6/8 • Number of events 6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
Gastrointestinal disorders Dysphagia	66.7% 4/6 • Number of events 4 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	75.0% 6/8 • Number of events 6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
Metabolism and nutrition disorders Anorexia	83.3% 5/6 • Number of events 5 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	75.0% 6/8 • Number of events 6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
Nervous system disorders Dysgeusia	100.0% 6/6 • Number of events 6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	87.5% 7/8 • Number of events 7 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
Respiratory, thoracic and mediastinal disorders Voice alteration	33.3% 2/6 • Number of events 2 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	50.0% 4/8 • Number of events 4 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
General disorders Neck edema	33.3% 2/6 • Number of events 2 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	12.5% 1/8 • Number of events 1 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
Injury, poisoning and procedural complications Dermatitis radiation	100.0% 6/6 • Number of events 6 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.	62.5% 5/8 • Number of events 5 • Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed. CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.

Additional Information

Jared Robbins, MD

University of Arizona Cancer Center

Phone: 520-626-6724

Email: jrobbins@arizona.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place