Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	NCCTG-N01C4 NCI-P02-0224, N01C4, NCT00036881

Objectives

1. Determine whether zinc sulfate prolongs the time to onset of altered taste in patients with head and neck cancer undergoing radiotherapy.
2. Determine whether this drug decreases the overall incidence of altered taste in these patients.
3. Determine whether this drug results in fewer radiotherapy treatment interruptions in these patients.
4. Assess the quality of life of patients treated with this drug.
5. Determine the toxic effects of this drug in these patients.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• No prior surgery that included ablation or removal of the olfactory component of taste

Other:

• No concurrent zinc supplements
  • Concurrent standard multivitamins allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

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

Expected Enrollment

A total of 168 patients (84 per treatment arm) will be accrued for this study.

Outcomes

Prolongation of the time to onset of altered taste by zinc sulfate

Incidence of taste alteration

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.

Halyard MY, Jatoi A, Sloan JA, et al.: 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 67 (5): 1318-22, 2007.[PUBMED Abstract]

Halyard MY, Jatoi A, Sloan JA, et al.: Does zinc sulfate to prevent radiation-induced taste alterations (“dysgeusia”) in head and neck cancer patients? A North Central Cancer Treatment Group (NCCTG) placebo-controlled trial (N01C4). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2367, S414, 2006.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-4918

Registry Information
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
Trial Start Date		2002-05-31
Registered in ClinicalTrials.gov		NCT00036881
Date Submitted to PDQ		2002-03-14
Information Last Verified		2005-09-23
NCI Grant/Contract Number		CA31946

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