Zinc Sulfate in Preventing Loss of Sense of Taste in Patients Undergoing Radiation Therapy for Head and Neck Cancer
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: zinc sulfate
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. |
|
|
Placebo Comparator: placebo
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prolongation of the time to onset of altered taste by zinc sulfate
Time Frame: Up to 1.5 years
|
Up to 1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of taste alteration
Time Frame: Up to 1.5 years
|
Up to 1.5 years
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCTG-N01C4
- NCI-2012-02465 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- NCI-P02-0224
- CDR0000069337 (Registry Identifier: PDQ (Physician Data Query))
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