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About
RATIONALE: It is not yet known whether zinc sulfate is effective in preventing the loss of ability to taste food in cancer patients who are undergoing radiation therapy for head and neck cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of zinc sulfate in preventing loss of sense of taste in patients who are undergoing radiation therapy for head and neck cancer.
Full description
OBJECTIVES:
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.
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.
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
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PRIOR CONCURRENT THERAPY:
Surgery:
Other:
No concurrent zinc supplements
Primary purpose
Allocation
Interventional model
Masking
173 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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