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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036881
• Other study ID #: NCCTG-N01C4
• Secondary ID: NCI-2012-02465NC
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2002
• Last updated: July 12, 2016
• Start date: May 2002
• Est. completion date: June 2007

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dysgeusia
• Head and Neck Cancer
• Head and Neck Neoplasms
• Oral Complications
• Radiation Toxicity

Intervention

Dietary Supplement:
• zinc sulfate

Other:
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

References & Publications (2)

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- — View Citation

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 Radia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolongation of the time to onset of altered taste by zinc sulfate		Up to 1.5 years	No
Secondary	Incidence of taste alteration		Up to 1.5 years	No