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 A subject discovered mold in the IP and all IP was returned to manufacturer and the 8 subjects were withdrawn from study.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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
61.5 years
n=99 Participants
|
64 years
n=107 Participants
|
61.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
HNC staging
Stage I
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
HNC staging
Stage II
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
HNC staging
Stage III
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
HNC staging
Stage IV
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Karnofsky Performance Score
|
90 Score on a scale
n=99 Participants
|
90 Score on a scale
n=107 Participants
|
90 Score on a scale
n=206 Participants
|
|
Number of teeth
|
22 teeth
n=99 Participants
|
28.5 teeth
n=107 Participants
|
25 teeth
n=206 Participants
|
|
General dental condition
Fair
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
General dental condition
Good
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
General dental condition
Excellent
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Oral Mucositis (OM) Grade
0 (none)
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Oral Mucositis (OM) Grade
1 (mild)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Oral Mucositis (OM) Grade
2 (moderate)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Oral Mucositis (OM) Grade
3 (severe)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Oral Mucositis (OM) Grade
4 (life-threatening)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Oral Mucositis (OM) Grade
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post radiotherapyWill 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 radiotherapyWill 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 radiotherapywill 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 radiotherapyPopulation: 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 radiotherapyPopulation: 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 radiotherapyPopulation: 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 radiotherapyPopulation: 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.
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Injury, poisoning and procedural complications
Dermatitis radiation
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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.
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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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place