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: Completed
• Conditions: Head and Neck Cancer; Radiation Toxicity; Dysgeusia; Oral Complications
• Intervention / Treatment: Other: placebo; Dietary supplement: zinc sulfate

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: Interventional
• Enrollment (Actual): 173
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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.	Dietary supplement: zinc sulfate
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.	Other: placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Halyard MY, Jatoi A, Sloan JA, Bearden JD 3rd, Vora SA, Atherton PJ, Perez EA, Soori G, Zalduendo AC, Zhu A, Stella PJ, Loprinzi CL. Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4). Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1318-22. doi: 10.1016/j.ijrobp.2006.10.046.

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: May 13, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): July 14, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Sensation Disorders; Taste Disorders; Head and Neck Neoplasms; Dysgeusia; Physiological Effects of Drugs; Dermatologic Agents; Astringents; Zinc Sulfate
• 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))