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Trial record 4 of 71 for:    Taste Disorders | NIH

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

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ClinicalTrials.gov Identifier: NCT00036881
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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.


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

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  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2002
Actual Primary Completion Date : April 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Prolongation of the time to onset of altered taste by zinc sulfate [ Time Frame: Up to 1.5 years ]

Secondary Outcome Measures :
  1. Incidence of taste alteration [ Time Frame: Up to 1.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036881


Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic

Publications of Results:
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 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
NCI-P02-0224
CDR0000069337 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Taste Disorders
Sensation Disorders
Nervous System Diseases
Head and Neck Neoplasms
Dysgeusia
Neoplasms by Site
Neoplasms
Neurologic Manifestations
Signs and Symptoms
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents