Mucositis Clinical Trial
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
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.
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