TriangleNCT02123511 · STUDY IN CONTEXT
Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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).
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).
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).
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).
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).
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).
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC
Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- qol key
- qol-0006
- source section id
- NCT02123511-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC
- measure definition
- 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.
- time frame
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores representing worse
- population note
- Patients who completed the QLQ H\&N Pain at all specified time points are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC Quality of Life Questionnaire (QLQ) Swallowing
Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- qol key
- qol-0007
- source section id
- NCT02123511-om-0007
- source outcome index
- 7
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC Quality of Life Questionnaire (QLQ) Swallowing
- measure definition
- 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.
- time frame
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores representing worse
- population note
- Patients who completed the QLQ H\&N Swallowing at all specified time points are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC
Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- qol key
- qol-0008
- source section id
- NCT02123511-om-0008
- source outcome index
- 8
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC
- measure definition
- 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.
- time frame
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores representing worse
- population note
- Patients who completed the QLQ H\&N Sticky Saliva at all specified time points are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- trial label
- Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 3
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0000
- source section id
- NCT02123511-om-0000
- source outcome index
- 0
- endpoint
- Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC)
- endpoint definition
- 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).
- time origin
- Up to 2 weeks following radiotherapy
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- evaluable for Primary Endpoint (AUC for GRIX Sticky Saliva Total Score)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0001
- source section id
- NCT02123511-om-0001
- source outcome index
- 1
- endpoint
- Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC)
- endpoint definition
- 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).
- time origin
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- evaluable for Primary Endpoint we included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0002
- source section id
- NCT02123511-om-0002
- source outcome index
- 2
- endpoint
- Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC).
- endpoint definition
- 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).
- time origin
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- evaluable for Primary Endpoint we included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0003
- source section id
- NCT02123511-om-0003
- source outcome index
- 3
- endpoint
- GRIX Xerostomia Daytime AUC
- endpoint definition
- 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).
- time origin
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who completed the GRIX Xerostomia Daytime at all specified time points are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0004
- source section id
- NCT02123511-om-0004
- source outcome index
- 4
- endpoint
- GRIX Xerostomia Nighttime AUC
- endpoint definition
- 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).
- time origin
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who completed the GRIX Xerostomia Nighttime at all specified time points are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0005
- source section id
- NCT02123511-om-0005
- source outcome index
- 5
- endpoint
- GRIX Xerostiomia Total Score AUC
- endpoint definition
- 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).
- time origin
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who completed the GRIX Xerostomia Total Score at all specified time points are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A (Placebo)
- regimen
- 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.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B (Rincinol)
- regimen
- 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.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A (Placebo)
- regimen
- 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.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B (Rincinol)
- regimen
- 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.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A (Placebo)
- regimen
- 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.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B (Rincinol)
- regimen
- 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.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A (Placebo)
- regimen
- 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.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B (Rincinol)
- regimen
- 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.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm A (Placebo)
- regimen
- 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.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm B (Rincinol)
- regimen
- 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.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm A (Placebo)
- regimen
- 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.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm B (Rincinol)
- regimen
- 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.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02123511-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- harm key
- EG000
- source section id
- NCT02123511-ae
- event group key
- EG000
- event group label
- Arm A (Placebo)
- serious affected
- 5
- serious at risk
- 17
- other affected
- 15
- other at risk
- 17
- frequency threshold
- 0
- collection period
- Adverse events are collected weekly during radiotherapy management visits
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- harm key
- EG001
- source section id
- NCT02123511-ae
- event group key
- EG001
- event group label
- Arm B (Rincinol)
- serious affected
- 0
- serious at risk
- 16
- other affected
- 14
- other at risk
- 16
- frequency threshold
- 0
- collection period
- Adverse events are collected weekly during radiotherapy management visits
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- qol key
- qol-0006
- source section id
- NCT02123511-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC
- measure definition
- 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.
- time frame
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores representing worse
- population note
- Patients who completed the QLQ H\&N Pain at all specified time points are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- qol key
- qol-0007
- source section id
- NCT02123511-om-0007
- source outcome index
- 7
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC Quality of Life Questionnaire (QLQ) Swallowing
- measure definition
- 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.
- time frame
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores representing worse
- population note
- Patients who completed the QLQ H\&N Swallowing at all specified time points are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
- nct id
- NCT02123511
- qol key
- qol-0008
- source section id
- NCT02123511-om-0008
- source outcome index
- 8
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC
- measure definition
- 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.
- time frame
- Up to 90 days after completion of radiation therapy
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores representing worse
- population note
- Patients who completed the QLQ H\&N Sticky Saliva at all specified time points are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice