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

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
Head and Neck Cancer Oral Complications of Cancer and Cancer Therapy Radiation Toxicity	Drug: zinc sulfate	Phase III

MedlinePlus related topics:

Cancer Head and Neck Cancer Salivary Gland Disorders Tonsils and Adenoids

ChemIDplus related topics:

Zinc sulfate Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

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

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

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

Publications of Results:

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
First Received:	May 13, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00036881
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

oral complications of cancer and cancer therapy

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

stage III verrucous carcinoma of the larynx

Study placed in the following topic categories:

Squamous cell carcinoma

Salicylsalicylic acid

Sodium Salicylate

Carcinoma, Basal Cell

Granuloma

Adenoid cystic carcinoma

Recurrence

Carcinoma

Epidermoid carcinoma

Nasopharyngeal carcinoma

Carcinoma, Adenoid Cystic

Zinc Sulfate

Metastatic squamous neck cancer with occult primary

Head and Neck Neoplasms

Zinc

Carcinoma, squamous cell

Laryngeal carcinoma

Hypopharyngeal cancer

Carcinoma, Squamous Cell

Papilloma

Salivary Gland Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Therapeutic Uses

Physiological Effects of Drugs

Astringents

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00036881