Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis 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.

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