Head and Neck Cancer Clinical Trial
Official title:
Phase III Double-Blind, Placebo-Controlled Randomized Comparison Of Zinc Sulfate Versus Placebo For The Prevention Of Altered Taste In Patients With Head And Neck Cancer During Radiation
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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