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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02123511
First Posted: April 25, 2014
Last Update Posted: March 22, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
  Purpose
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.

Condition Intervention
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 Other: placebo Other: quality-of-life assessment Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 18
Actual Study Start Date: April 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: acetylcysteine
Oral rinse
Other Names:
  • Airbron
  • Broncholysin
  • Brunac
  • N-acetylcysteine
  • NAC
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
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.
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123511


Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michele Halyard Mayo Clinic
  More 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
Last Update Posted: March 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Laryngeal Diseases
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Carcinoma, Verrucous
Mucositis
Carcinoma, Basal Cell
Nasopharyngeal Neoplasms
Salivary Gland Neoplasms
Carcinoma, Adenoid Cystic
Carcinoma, Mucoepidermoid
Tongue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Pharyngeal Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases


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