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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 23, 2014
First Posted Date  ICMJE April 25, 2014
Results First Submitted Date  ICMJE December 17, 2018
Results First Posted Date  ICMJE April 5, 2019
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date March 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC) [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2014)
Area under the curve (AUC) of the GRIX sticky saliva total score [ Time Frame: Up to 2 weeks following radiotherapy ]
Calculated for each patient from baseline to 2 weeks following radiotherapy. The AUC values will be compared between the two arms using either t-tests or Wilcoxon nonparametric tests and tested for normality using the Shapiro-Wilk test. If the normality assumption is rejected at a 0.20 level, Wilcoxon tests will be used to compare the AUC values between arms. If the normality assumption is not rejected, an F test will be used to compare the variances of the AUC values between the two arms at the 0.20 level.
Change History Complete list of historical versions of study NCT02123511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC) [ Time Frame: 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).
  • Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC). [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
  • EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC [ Time Frame: 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.
  • EORTC Quality of Life Questionnaire (QLQ) Swallowing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2014)
  • Scores for sticky saliva during the day, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
    AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
  • Scores for sticky saliva during the night, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
    AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
  • Scores for xerostomia during the day, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
    AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
  • Scores for xerostomia during the night, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
    AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
  • Xerostomia total scores, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
    AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
  • QLQ-H&N35 scores [ Time Frame: Up to 90 days after completion of radiation therapy ]
    Scores will be compared between the two arms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Official Title  ICMJE A Randomized, Double-Blind Pilot Study of N-Acetylcysteine Mucoadherent Rinse Versus Placebo for Thickened Secretions and Mucositis Secondary to Chemoradiotherapy in the Management of Head and Neck Malignancies
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: acetylcysteine
    Oral rinse
    Other Names:
    • Airbron
    • Broncholysin
    • Brunac
    • N-acetylcysteine
    • NAC
  • Other: placebo
    Oral rinse
    Other Name: PLCB
  • Other: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Other: questionnaire administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm I (acetylcysteine)
    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.
    Interventions:
    • Drug: acetylcysteine
    • Other: quality-of-life assessment
    • Other: questionnaire administration
  • Placebo Comparator: Arm II (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.
    Interventions:
    • Other: placebo
    • Other: quality-of-life assessment
    • Other: questionnaire administration
Publications * Sio TT, Blanchard MJ, Novotny PJ, Patel SH, Rwigema JM, Pederson LD, McGee LA, Gamez ME, Seeger GR, Martenson JA, Grover Y, Neben Wittich MA, Garces YI, Foote RL, Miller RC, Halyard MY. N-Acetylcysteine Rinse for Thick Secretion and Mucositis of Head and Neck Chemoradiotherapy (Alliance MC13C2): A Double-Blind Randomized Clinical Trial. Mayo Clin Proc. 2019 Sep;94(9):1814-1824. doi: 10.1016/j.mayocp.2019.03.031. Epub 2019 Aug 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
34
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2014)
36
Actual Study Completion Date  ICMJE July 2, 2018
Actual Primary Completion Date March 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02123511
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Michele Halyard Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP