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 II Adenoid Cystic Carcinoma of the Oral Cavity, Stage II Basal Cell Carcinoma of the Lip, 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 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 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 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, Stage I Verrucous Carcinoma of the Larynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage IV Lymphoepithelioma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Tongue Cancer
Conditions
Brief summary
This randomized pilot clinical trial studies whether acetylcysteine oral rinse will lessen saliva thickness and painful mouth sores in patients with head and neck cancer undergoing radiation therapy. Side effects from radiation therapy to the head and neck, such as thickened saliva and mouth sores, may interfere with activities of daily living such as eating and drinking, and may also cause treatment to be stopped or delayed. Acetylcysteine rinse may reduce saliva thickness and mouth sores, and improve quality of life in patients with head and neck cancer undergoing radiation therapy.
Detailed description
PRIMARY OBJECTIVES: I. To determine the effectiveness of N-acetylcysteine (acetylcysteine) in improving saliva viscosity (as measured by the Groningen Radiotherapy-Induced Xerostomia \[GRIX\]) in patients undergoing chemotherapy and radiotherapy for head and neck cancer. SECONDARY OBJECTIVES: I. To determine whether N-acetylcysteine (NAC) can improve other GRIX subscale for patients undergoing chemotherapy and radiotherapy for head and neck cancer. II. To determine whether NAC can improve patient reported quality of life as measured by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ) Head & Neck (H&N)35. III. To assess the adverse event profile of NAC as measured by the Common Terminology Criteria for Adverse Events (CTCAE) every week during radiation. IV. To determine patient adherence to N-acetylcysteine mucoadherent rinse using patient reported surveys. V. To determine the long-term benefits of N-acetylcysteine as measured by the GRIX questionnaire at 45 days and 90 days post treatment. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: 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. ARM II: 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. After completion of study treatment, patients are followed up at 45 and 90 days.
Interventions
Oral rinse
Oral rinse
Ancillary studies
Ancillary studies
Sponsors
Study design
Eligibility
Inclusion criteria
* Histological confirmation of tumor of the oral cavity, oropharynx, supraglottic larynx, or nasopharynx * Receiving concurrent chemoradiotherapy/chemobiotherapy to a minimum dose equivalent to 60 Gy in 30 fractions in the adjuvant or definitive setting * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Initiation of investigational agent =\< 3 days after initiation of radiotherapy * Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only * Ability to complete questionnaire(s) by themselves or with assistance * Provide informed written consent * Willing to return mail-in questionnaires during the observation phase of the study
Exclusion criteria
* Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Receipt of induction chemotherapy * Previous receipt of head and neck irradiation * Utilization of amifostine during radiotherapy * Greater than or equal to grade 2 dry mouth prior to chemoradiotherapy or greater than or equal to grade 2 mucositis * Previous intolerance/adverse effect/allergy to any component of the placebo or active agent * History of Sjogren's, lupus or scleroderma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC) | Up to 2 weeks following radiotherapy | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC). | Up to 90 days after completion of radiation therapy | 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 | Up to 90 days after completion of radiation therapy | 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 | Up to 90 days after completion of radiation therapy | 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 | Up to 90 days after completion of radiation therapy | 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). |
| Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC) | Up to 90 days after completion of radiation therapy | 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). |
| EORTC Quality of Life Questionnaire (QLQ) Swallowing | Up to 90 days after completion of radiation therapy | 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. |
| EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC | Up to 90 days after completion of radiation therapy | 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. |
| Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | 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. |
| EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC | Up to 90 days after completion of radiation therapy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 15 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancelled treatment | 1 | 0 |
| Overall Study | Incomplete data | 1 | 3 |
| Overall Study | Ineligible | 0 | 1 |
Baseline characteristics
| Characteristic | Arm A (Placebo) | Arm B (Rincinol) | Total |
|---|---|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 10.3 | 60.9 years STANDARD_DEVIATION 10.3 | 58.3 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 17 Participants | 15 Participants | 32 Participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 15 / 17 | 14 / 16 |
| serious Total, serious adverse events | 5 / 17 | 0 / 16 |
Outcome results
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC)
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
Population: evaluable for Primary Endpoint (AUC for GRIX Sticky Saliva Total Score)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Placebo) | Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC) | 40.9 score on a scale | Standard Deviation 23.7 |
| Arm B (Rincinol) | Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC) | 27.2 score on a scale | Standard Deviation 21 |
Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Placebo) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Grade 0 | 2 Participants |
| Arm A (Placebo) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Grade 2 | 4 Participants |
| Arm A (Placebo) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Grade 1 | 3 Participants |
| Arm A (Placebo) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Grade 3 | 8 Participants |
| Arm A (Placebo) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Missing | 0 Participants |
| Arm B (Rincinol) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Grade 3 | 3 Participants |
| Arm B (Rincinol) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Missing | 1 Participants |
| Arm B (Rincinol) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Grade 0 | 0 Participants |
| Arm B (Rincinol) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Grade 1 | 5 Participants |
| Arm B (Rincinol) | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event | Grade 2 | 6 Participants |
EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC
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
Population: Patients who completed the QLQ H\&N Pain at all specified time points are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Placebo) | EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC | 32.4 score on a scale | Standard Deviation 15.3 |
| Arm B (Rincinol) | EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC | 32.0 score on a scale | Standard Deviation 13.9 |
EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC
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
Population: Patients who completed the QLQ H\&N Sticky Saliva at all specified time points are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Placebo) | EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC | 46.3 score on a scale | Standard Deviation 22.8 |
| Arm B (Rincinol) | EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC | 37.9 score on a scale | Standard Deviation 28.5 |
EORTC Quality of Life Questionnaire (QLQ) Swallowing
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
Population: Patients who completed the QLQ H\&N Swallowing at all specified time points are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Placebo) | EORTC Quality of Life Questionnaire (QLQ) Swallowing | 34.7 score on a scale | Standard Deviation 18.8 |
| Arm B (Rincinol) | EORTC Quality of Life Questionnaire (QLQ) Swallowing | 22.3 score on a scale | Standard Deviation 17.6 |
GRIX Xerostiomia Total Score AUC
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
Population: Patients who completed the GRIX Xerostomia Total Score at all specified time points are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Placebo) | GRIX Xerostiomia Total Score AUC | 43.8 score on a scale | Standard Deviation 14.7 |
| Arm B (Rincinol) | GRIX Xerostiomia Total Score AUC | 28.5 score on a scale | Standard Deviation 17.6 |
GRIX Xerostomia Daytime AUC
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
Population: Patients who completed the GRIX Xerostomia Daytime at all specified time points are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Placebo) | GRIX Xerostomia Daytime AUC | 44.1 score on a scale | Standard Deviation 17.8 |
| Arm B (Rincinol) | GRIX Xerostomia Daytime AUC | 27.3 score on a scale | Standard Deviation 17.9 |
GRIX Xerostomia Nighttime AUC
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
Population: Patients who completed the GRIX Xerostomia Nighttime at all specified time points are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Placebo) | GRIX Xerostomia Nighttime AUC | 39.8 score on a scale | Standard Deviation 16.4 |
| Arm B (Rincinol) | GRIX Xerostomia Nighttime AUC | 31.3 score on a scale | Standard Deviation 19.6 |
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC)
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
Population: evaluable for Primary Endpoint we included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Placebo) | Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC) | 45.2 score on a scale | Standard Deviation 26.4 |
| Arm B (Rincinol) | Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC) | 26.1 score on a scale | Standard Deviation 18.7 |
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC).
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
Population: evaluable for Primary Endpoint we included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Placebo) | Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC). | 34.5 score on a scale | Standard Deviation 22.8 |
| Arm B (Rincinol) | Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC). | 29.1 score on a scale | Standard Deviation 26.3 |