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

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ClinicalTrials.gov Identifier: NCT02123511
Recruitment Status : Completed
First Posted : April 25, 2014
Results First Posted : April 5, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Mucositis
Oral Complications
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Basal Cell Carcinoma of the Lip
Recurrent Lymphoepithelioma of the Nasopharynx
Recurrent Lymphoepithelioma of the Oropharynx
Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Stage I Adenoid Cystic Carcinoma of the Oral Cavity
Stage I Basal Cell Carcinoma of the Lip
Stage I Lymphoepithelioma of the Nasopharynx
Stage I Lymphoepithelioma of the Oropharynx
Stage I Mucoepidermoid Carcinoma of the Oral Cavity
Stage I Salivary Gland Cancer
Stage I Squamous Cell Carcinoma of the Larynx
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage I Squamous Cell Carcinoma of the Nasopharynx
Stage I Squamous Cell Carcinoma of the Oropharynx
Stage I Verrucous Carcinoma of the Larynx
Stage I Verrucous Carcinoma of the Oral Cavity
Stage II Adenoid Cystic Carcinoma of the Oral Cavity
Stage II Basal Cell Carcinoma of the Lip
Stage II Lymphoepithelioma of the Nasopharynx
Stage II Lymphoepithelioma of the Oropharynx
Stage II Mucoepidermoid Carcinoma of the Oral Cavity
Stage II Salivary Gland Cancer
Stage II Squamous Cell Carcinoma of the Larynx
Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage II Squamous Cell Carcinoma of the Nasopharynx
Stage II Squamous Cell Carcinoma of the Oropharynx
Stage II Verrucous Carcinoma of the Larynx
Stage II Verrucous Carcinoma of the Oral Cavity
Stage III Adenoid Cystic Carcinoma of the Oral Cavity
Stage III Basal Cell Carcinoma of the Lip
Stage III Lymphoepithelioma of the Nasopharynx
Stage III Lymphoepithelioma of the Oropharynx
Stage III Mucoepidermoid Carcinoma of the Oral Cavity
Stage III Salivary Gland Cancer
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Verrucous Carcinoma of the Larynx
Stage III Verrucous Carcinoma of the Oral Cavity
Stage IV Lymphoepithelioma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity
Stage IVA Basal Cell Carcinoma of the Lip
Stage IVA Lymphoepithelioma of the Oropharynx
Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity
Stage IVA Salivary Gland Cancer
Stage IVA Squamous Cell Carcinoma of the Larynx
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Oropharynx
Stage IVA Verrucous Carcinoma of the Larynx
Stage IVA Verrucous Carcinoma of the Oral Cavity
Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity
Stage IVB Basal Cell Carcinoma of the Lip
Stage IVB Lymphoepithelioma of the Oropharynx
Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity
Stage IVB Salivary Gland Cancer
Stage IVB Squamous Cell Carcinoma of the Larynx
Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Oropharynx
Stage IVB Verrucous Carcinoma of the Larynx
Stage IVB Verrucous Carcinoma of the Oral Cavity
Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity
Stage IVC Basal Cell Carcinoma of the Lip
Stage IVC Lymphoepithelioma of the Oropharynx
Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity
Stage IVC Salivary Gland Cancer
Stage IVC Squamous Cell Carcinoma of the Larynx
Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVC Squamous Cell Carcinoma of the Oropharynx
Stage IVC Verrucous Carcinoma of the Larynx
Stage IVC Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Interventions Drug: acetylcysteine
Other: placebo
Other: quality-of-life assessment
Other: questionnaire administration
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 18 16
Eligible Patients 17 15
Completed [1] 16 12
Not Completed 2 4
Reason Not Completed
Cancelled treatment             1             0
Incomplete data             1             3
Ineligible             0             1
[1]
evaluable for Primary Endpoint (AUC for GRIX Sticky Saliva Total Score)
Arm/Group Title Arm A (Placebo) Arm B (Rincinol) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 17 15 32
Hide Baseline Analysis Population Description
Eligible patients are included in this participant flow.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 15 participants 32 participants
55.9  (10.3) 60.9  (10.3) 58.3  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 32 participants
Female
6
  35.3%
4
  26.7%
10
  31.3%
Male
11
  64.7%
11
  73.3%
22
  68.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants 15 participants 32 participants
17
 100.0%
15
 100.0%
32
 100.0%
1.Primary Outcome
Title Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC)
Hide Description 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 Frame Up to 2 weeks following radiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
evaluable for Primary Endpoint (AUC for GRIX Sticky Saliva Total Score)
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 16 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
40.9  (23.7) 27.2  (21.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1232
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Secondary Outcome
Title Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC)
Hide Description 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 Frame Up to 90 days after completion of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
evaluable for Primary Endpoint we included in this analysis.
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 16 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
45.2  (26.4) 26.1  (18.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0422
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC).
Hide Description 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 Frame Up to 90 days after completion of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
evaluable for Primary Endpoint we included in this analysis.
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 16 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
34.5  (22.8) 29.1  (26.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5634
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
4.Secondary Outcome
Title GRIX Xerostomia Daytime AUC
Hide Description 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 Frame Up to 90 days after completion of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the GRIX Xerostomia Daytime at all specified time points are included in this analysis.
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
44.1  (17.8) 27.3  (17.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
5.Secondary Outcome
Title GRIX Xerostomia Nighttime AUC
Hide Description 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 Frame Up to 90 days after completion of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the GRIX Xerostomia Nighttime at all specified time points are included in this analysis.
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 16 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
39.8  (16.4) 31.3  (19.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
6.Secondary Outcome
Title GRIX Xerostiomia Total Score AUC
Hide Description 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 Frame Up to 90 days after completion of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the GRIX Xerostomia Total Score at all specified time points are included in this analysis.
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
43.8  (14.7) 28.5  (17.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
7.Secondary Outcome
Title EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the QLQ H&N Pain at all specified time points are included in this analysis.
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 12 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
32.4  (15.3) 32.0  (13.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
8.Secondary Outcome
Title EORTC Quality of Life Questionnaire (QLQ) Swallowing
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the QLQ H&N Swallowing at all specified time points are included in this analysis.
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
34.7  (18.8) 22.3  (17.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
9.Secondary Outcome
Title EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the QLQ H&N Sticky Saliva at all specified time points are included in this analysis.
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 12 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
46.3  (22.8) 37.9  (28.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
10.Secondary Outcome
Title Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event
Hide Description 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.
Time Frame Up to 90 days after completion of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 17 15
Measure Type: Count of Participants
Unit of Measure: Participants
Missing
0
   0.0%
1
   6.7%
Grade 0
2
  11.8%
0
   0.0%
Grade 1
3
  17.6%
5
  33.3%
Grade 2
4
  23.5%
6
  40.0%
Grade 3
8
  47.1%
3
  20.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Placebo), Arm B (Rincinol)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3824
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Adverse events are collected weekly during radiotherapy management visits
Adverse Event Reporting Description 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.
 
Arm/Group Title Arm A (Placebo) Arm B (Rincinol)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Arm A (Placebo) Arm B (Rincinol)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Placebo) Arm B (Rincinol)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/17 (29.41%)      0/16 (0.00%)    
Gastrointestinal disorders     
Dysphagia  1  1/17 (5.88%)  1 0/16 (0.00%)  0
Nausea  1  1/17 (5.88%)  1 0/16 (0.00%)  0
Oral hemorrhage  1  1/17 (5.88%)  1 0/16 (0.00%)  0
Oral pain  1  1/17 (5.88%)  1 0/16 (0.00%)  0
Infections and infestations     
Lung infection  1  1/17 (5.88%)  1 0/16 (0.00%)  0
Investigations     
White blood cell decreased  1  1/17 (5.88%)  1 0/16 (0.00%)  0
Nervous system disorders     
Dysgeusia  1  1/17 (5.88%)  1 0/16 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A (Placebo) Arm B (Rincinol)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/17 (88.24%)      14/16 (87.50%)    
Gastrointestinal disorders     
Abdominal pain  1  5/17 (29.41%)  8 3/16 (18.75%)  6
Dry mouth  1  1/17 (5.88%)  4 0/16 (0.00%)  0
Dysphagia  1  1/17 (5.88%)  2 1/16 (6.25%)  1
Mucositis oral  1  3/17 (17.65%)  6 3/16 (18.75%)  3
Nausea  1  11/17 (64.71%)  28 7/16 (43.75%)  13
Oral hemorrhage  1  4/17 (23.53%)  10 2/16 (12.50%)  7
Oral pain  1  11/17 (64.71%)  47 8/16 (50.00%)  31
Investigations     
Creatinine increased  1  1/17 (5.88%)  2 0/16 (0.00%)  0
Weight loss  1  1/17 (5.88%)  1 0/16 (0.00%)  0
Nervous system disorders     
Dysgeusia  1  1/17 (5.88%)  4 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/17 (0.00%)  0 1/16 (6.25%)  1
Hoarseness  1  1/17 (5.88%)  3 0/16 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michele Halyard, M.D.; Robert Foote, M.D.
Organization: Mayo Clinic
Phone: 480-301-4567
EMail: mhalyard@mayo.edu; foote.robert@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT02123511     History of Changes
Other Study ID Numbers: MC13C2
NCI-2014-00865 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Mod13-007632-07
MC13C2 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: April 23, 2014
First Posted: April 25, 2014
Results First Submitted: December 17, 2018
Results First Posted: April 5, 2019
Last Update Posted: April 30, 2019