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

NCT ID: NCT00036881

Last Updated: 2016-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2007-06-30

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.

Conditions

Dysgeusia; Head and Neck Cancer; Oral Complications; Radiation Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

zinc sulfate

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Interventions

zinc sulfate

Intervention Type: DIETARY_SUPPLEMENT

placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aminah Jatoi, MD

Role: STUDY_CHAIR

Mayo Clinic

References

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.

Reference Type: RESULT

PMID: 17394940 (View on PubMed)

Other Identifiers

NCI-2012-02465

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-P02-0224

Identifier Type: -

Identifier Source: secondary_id

CDR0000069337

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-N01C4

Identifier Type: -

Identifier Source: org_study_id