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

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00036881

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	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
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:

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders Taste and Smell Disorders Tonsils and Adenoids

Drug Information available for: Zinc sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Incidence of taste alteration

Study Start Date:

May 2002

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.

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

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

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

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

Contacts and Locations

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

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Aminah Jatoi, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Study ID Numbers:	CDR0000069337, NCCTG-N01C4, NCI-P02-0224
Study First Received:	May 13, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00036881 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

dysgeusia
oral complications
radiation toxicity
stage I lymphoepithelioma of the nasopharynx
stage I squamous cell carcinoma of the nasopharynx
stage II lymphoepithelioma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary

recurrent squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx

Additional relevant MeSH terms:

Sensation Disorders
Dysgeusia
Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Trace Elements
Pharmacologic Actions
Taste Disorders
Signs and Symptoms
Neoplasms

Neoplasms by Site
Zinc Sulfate
Therapeutic Uses
Head and Neck Neoplasms
Zinc
Astringents
Neurologic Manifestations
Micronutrients
Dermatologic Agents

ClinicalTrials.gov processed this record on November 22, 2009