Zinc Sulfate in Preventing Loss of Sense of Taste in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Dysgeusia, Head and Neck Cancer, Oral Complications
About this trial
This is an interventional supportive care trial for Dysgeusia
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of head and neck cancer No stage I laryngeal cancer Planned treatment with at least 2,000 cGy of external beam radiotherapy to at least 30% of the oral cavity PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Gastrointestinal: Able to tolerate oral medication No known mechanical obstruction of the alimentary tract No malabsorption No intractable vomiting (more than 5 episodes per week) Other: No known intolerance to zinc sulfate No known, untreated oral thrush Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Surgery: No prior surgery that included ablation or removal of the olfactory component of taste Other: No concurrent zinc supplements Concurrent standard multivitamins allowed
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
zinc sulfate
placebo
Patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy. Treatment continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity. Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment. Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year.
Patients receive oral placebo 3 times daily beginning the first week of radiotherapy. Treatment continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity. Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment. Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year.