Trial Outcomes & Findings for Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy (NCT NCT02123511)

NCT ID: NCT02123511

Last Updated: 2019-04-30

Results Overview

Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva total score Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: Up to 2 weeks following radiotherapy
• Results posted on: 2019-04-30

Participant Flow

Participant milestones

Measure	Arm A (Placebo) Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Overall Study STARTED	18	16
Overall Study Eligible Patients	17	15
Overall Study COMPLETED	16	12
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Arm A (Placebo) Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Overall Study Cancelled treatment	1	0
Overall Study Incomplete data	1	3
Overall Study Ineligible	0	1

Baseline Characteristics

Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy

Baseline characteristics by cohort

Measure	Arm A (Placebo) n=17 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=15 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Total n=32 Participants Total of all reporting groups
Age, Continuous	55.9 years STANDARD_DEVIATION 10.3 • n=5 Participants	60.9 years STANDARD_DEVIATION 10.3 • n=7 Participants	58.3 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks following radiotherapy

Population: evaluable for Primary Endpoint (AUC for GRIX Sticky Saliva Total Score)

Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva total score Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).

Outcome measures

Measure	Arm A (Placebo) n=16 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=12 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC)	40.9 score on a scale Standard Deviation 23.7	27.2 score on a scale Standard Deviation 21.0

SECONDARY outcome

Timeframe: Up to 90 days after completion of radiation therapy

Population: evaluable for Primary Endpoint we included in this analysis.

Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva Daytime Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).

Outcome measures

Measure	Arm A (Placebo) n=16 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=12 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC)	45.2 score on a scale Standard Deviation 26.4	26.1 score on a scale Standard Deviation 18.7

SECONDARY outcome

Timeframe: Up to 90 days after completion of radiation therapy

Population: evaluable for Primary Endpoint we included in this analysis.

Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva Nighttime Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).

Outcome measures

Measure	Arm A (Placebo) n=16 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=12 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC).	34.5 score on a scale Standard Deviation 22.8	29.1 score on a scale Standard Deviation 26.3

SECONDARY outcome

Timeframe: Up to 90 days after completion of radiation therapy

Population: Patients who completed the GRIX Xerostomia Daytime at all specified time points are included in this analysis.

GRIX Xerostomia Daytime AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).

Outcome measures

Measure	Arm A (Placebo) n=14 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=12 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
GRIX Xerostomia Daytime AUC	44.1 score on a scale Standard Deviation 17.8	27.3 score on a scale Standard Deviation 17.9

SECONDARY outcome

Timeframe: Up to 90 days after completion of radiation therapy

Population: Patients who completed the GRIX Xerostomia Nighttime at all specified time points are included in this analysis.

GRIX Xerostomia Nighttime AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).

Outcome measures

Measure	Arm A (Placebo) n=16 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=12 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
GRIX Xerostomia Nighttime AUC	39.8 score on a scale Standard Deviation 16.4	31.3 score on a scale Standard Deviation 19.6

SECONDARY outcome

Timeframe: Up to 90 days after completion of radiation therapy

Population: Patients who completed the GRIX Xerostomia Total Score at all specified time points are included in this analysis.

GRIX Xerostiomia Total Score AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).

Outcome measures

Measure	Arm A (Placebo) n=14 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=12 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
GRIX Xerostiomia Total Score AUC	43.8 score on a scale Standard Deviation 14.7	28.5 score on a scale Standard Deviation 17.6

SECONDARY outcome

Timeframe: Up to 90 days after completion of radiation therapy

Population: Patients who completed the QLQ H\&N Pain at all specified time points are included in this analysis.

Average Area Under the Curve per assessment (aAUCpa) of QLQ H&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, and weight gain. The QLQ H&N35 scoring algorithm was used for pain (questions 31-34) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale.

Outcome measures

Measure	Arm A (Placebo) n=12 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=8 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC	32.4 score on a scale Standard Deviation 15.3	32.0 score on a scale Standard Deviation 13.9

SECONDARY outcome

Timeframe: Up to 90 days after completion of radiation therapy

Population: Patients who completed the QLQ H\&N Swallowing at all specified time points are included in this analysis.

Average Area Under the Curve per assessment (aAUCpa) of QLQ H&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, & weight gain. The QLQ H&N35 scoring algorithm was used for swallowing (questions 35-38) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient & subscale, the subscale values at treatment-initiation & assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale.

Outcome measures

Measure	Arm A (Placebo) n=10 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=8 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
EORTC Quality of Life Questionnaire (QLQ) Swallowing	34.7 score on a scale Standard Deviation 18.8	22.3 score on a scale Standard Deviation 17.6

SECONDARY outcome

Timeframe: Up to 90 days after completion of radiation therapy

Population: Patients who completed the QLQ H\&N Sticky Saliva at all specified time points are included in this analysis.

Average Area Under the Curve per assessment (aAUCpa) of QLQ H&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, & weight gain. The QLQ H&N35 scoring algorithm was used for sticky saliva (question 42) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient & subscale, the subscale values at treatment-initiation & assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale.

Outcome measures

Measure	Arm A (Placebo) n=12 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=8 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC	46.3 score on a scale Standard Deviation 22.8	37.9 score on a scale Standard Deviation 28.5

SECONDARY outcome

Timeframe: Up to 90 days after completion of radiation therapy

The maximum grade for each type of toxicity will be recorded for each patient. The overall adverse event rates (percentages) for adverse events are reported below.

Outcome measures

Measure	Arm A (Placebo) n=17 Participants Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=15 Participants Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event Missing	0 Participants	1 Participants
Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event Grade 0	2 Participants	0 Participants
Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event Grade 1	3 Participants	5 Participants
Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event Grade 2	4 Participants	6 Participants
Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event Grade 3	8 Participants	3 Participants

Adverse Events

Arm A (Placebo)

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm B (Rincinol)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A (Placebo) n=17 participants at risk Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=16 participants at risk Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Gastrointestinal disorders Dysphagia	5.9% 1/17 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Oral hemorrhage	5.9% 1/17 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Oral pain	5.9% 1/17 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Lung infection	5.9% 1/17 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations White blood cell decreased	5.9% 1/17 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Nervous system disorders Dysgeusia	5.9% 1/17 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.

Other adverse events

Measure	Arm A (Placebo) n=17 participants at risk Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.	Arm B (Rincinol) n=16 participants at risk Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Gastrointestinal disorders Abdominal pain	29.4% 5/17 • Number of events 8 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	18.8% 3/16 • Number of events 6 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Dry mouth	5.9% 1/17 • Number of events 4 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Dysphagia	5.9% 1/17 • Number of events 2 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	6.2% 1/16 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Mucositis oral	17.6% 3/17 • Number of events 6 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	18.8% 3/16 • Number of events 3 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Nausea	64.7% 11/17 • Number of events 28 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	43.8% 7/16 • Number of events 13 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Oral hemorrhage	23.5% 4/17 • Number of events 10 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	12.5% 2/16 • Number of events 7 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Oral pain	64.7% 11/17 • Number of events 47 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	50.0% 8/16 • Number of events 31 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Creatinine increased	5.9% 1/17 • Number of events 2 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Weight loss	5.9% 1/17 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Nervous system disorders Dysgeusia	5.9% 1/17 • Number of events 4 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/17 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	6.2% 1/16 • Number of events 1 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.9% 1/17 • Number of events 3 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.	0.00% 0/16 • Adverse events are collected weekly during radiotherapy management visits Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.

Additional Information

Michele Halyard, M.D.; Robert Foote, M.D.

Mayo Clinic

Phone: 480-301-4567

Email: mhalyard@mayo.edu; foote.robert@mayo.edu

Results disclosure agreements

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