Zinc Sulfate in Preventing Loss of Sense of Taste in Patients Undergoing Radiation Therapy for Head and Neck Cancer

OBJECTIVES:

• Determine whether zinc sulfate prolongs the time to onset of altered taste in patients with head and neck cancer undergoing radiotherapy.
• Determine whether this drug decreases the overall incidence of altered taste in these patients.
• Determine whether this drug results in fewer radiotherapy treatment interruptions in these patients.
• Assess the quality of life of patients treated with this drug.
• Determine the toxic effects of this drug in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to planned radiotherapy dose (less than 6,000 cGy vs at least 6,000 cGy), estimated amount of oral mucosa in the radiation field (60% or less vs more than 60%), age (under 50 vs 50 and over), concurrent chemotherapy (yes vs no), and smoking (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy.
• Arm II: Patients receive oral placebo 3 times daily beginning the first week of radiotherapy.

Treatment in both arms 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.

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