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

Phase 3

Completed

• Conditions: Head and Neck Cancer; Radiation Toxicity; Oral Complications; Dysgeusia
• Interventions: Other: placebo; Dietary Supplement: zinc sulfate

• Registration Number: NCT00036881
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-05-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-04
• Study Completion: 2007-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	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.
zinc sulfate	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.

Primary Outcome Measures

Name	Time	Method
Prolongation of the time to onset of altered taste by zinc sulfate	Up to 1.5 years

Secondary Outcome Measures

Name	Time	Method
Incidence of taste alteration	Up to 1.5 years