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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 : Active, not recruiting
First Posted : April 25, 2014
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

April 23, 2014
April 25, 2014
April 18, 2018
April 2014
January 15, 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02123511 on ClinicalTrials.gov Archive Site
  • 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
  • Adverse event profile of NAC [ Time Frame: Up to 90 days after completion of radiation therapy ]
    The adverse event profile of NAC will be summarized by looking at the incidence and maximum severity of each adverse event.
  • 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
Not Provided
Not Provided
 
Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
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
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
  • 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
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
36
December 2018
January 15, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02123511
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 )
Not Provided
Not Provided
Not Provided
Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Michele Halyard Mayo Clinic
Mayo Clinic
April 2018

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