Dysgeusia, Head and Neck Cancer, Oral Complications, Radiation Toxicity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTzinc sulfate
OTHERplacebo
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prolongation of the time to onset of altered taste by zinc sulfate | Up to 1.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of taste alteration | Up to 1.5 years |
Outcome results
None listed