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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00036881
First received: May 13, 2002
Last updated: July 7, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Dysgeusia
Head and Neck Cancer
Oral Complications
Radiation Toxicity
Dietary Supplement: zinc sulfate
Other: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Prolongation of the time to onset of altered taste by zinc sulfate [ Time Frame: Up to 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of taste alteration [ Time Frame: Up to 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: May 2002
Study Completion Date: June 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036881

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
  More Information

Additional Information:
Publications:
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.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00036881     History of Changes
Other Study ID Numbers: NCCTG-N01C4, NCI-2012-02465, NCI-P02-0224, CDR0000069337
Study First Received: May 13, 2002
Last Updated: July 7, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Zinc
Zinc Sulfate
Astringents
Dermatologic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on July 30, 2015