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

Study Overview
=================
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.

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

Conditions
-----------------
Dysgeusia, Head and Neck Cancer, Oral Complications, Radiation Toxicity

Intervention / Treatment
-----------------
* Dietary Supplement: zinc sulfate
* Other: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zinc sulfate<br>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. | Dietary Supplement: zinc sulfate<br> <br> |
| Placebo Comparator: placebo<br>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. | Other: placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolongation of the time to onset of altered taste by zinc sulfate |  | Up to 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of taste alteration |  | Up to 1.5 years |