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
18 Years
N/A
Both
Dysgeusia, Head and Neck Cancer, Oral Complications, Radiation Toxicity
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Prolongation of the time to onset of altered taste by zinc sulfate
Principal Investigator
Aminah Jatoi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000069337
NCT ID:
NCT00036881
Start Date:
May 2002
Completion Date:
Related Keywords:
- Dysgeusia
- Head and Neck Cancer
- Oral Complications
- Radiation Toxicity
- 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
- stage III verrucous carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage IV verrucous carcinoma of the larynx
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent inverted papilloma of the paranasal sinus and nasal cavity
- recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage I inverted papilloma of the paranasal sinus and nasal cavity
- stage I midline lethal granuloma of the paranasal sinus and nasal cavity
- stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage II inverted papilloma of the paranasal sinus and nasal cavity
- stage II midline lethal granuloma of the paranasal sinus and nasal cavity
- stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage III inverted papilloma of the paranasal sinus and nasal cavity
- stage III midline lethal granuloma of the paranasal sinus and nasal cavity
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent lymphoepithelioma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage I lymphoepithelioma of the oropharynx
- stage I squamous cell carcinoma of the oropharynx
- stage II lymphoepithelioma of the oropharynx
- stage II squamous cell carcinoma of the oropharynx
- stage III lymphoepithelioma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- recurrent basal cell carcinoma of the lip
- stage I basal cell carcinoma of the lip
- stage II basal cell carcinoma of the lip
- stage III basal cell carcinoma of the lip
- stage IV basal cell carcinoma of the lip
- recurrent adenoid cystic carcinoma of the oral cavity
- recurrent mucoepidermoid carcinoma of the oral cavity
- recurrent verrucous carcinoma of the oral cavity
- stage I adenoid cystic carcinoma of the oral cavity
- stage I mucoepidermoid carcinoma of the oral cavity
- stage I verrucous carcinoma of the oral cavity
- stage II adenoid cystic carcinoma of the oral cavity
- stage II mucoepidermoid carcinoma of the oral cavity
- stage II verrucous carcinoma of the oral cavity
- stage III adenoid cystic carcinoma of the oral cavity
- stage III mucoepidermoid carcinoma of the oral cavity
- stage III verrucous carcinoma of the oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- stage IV mucoepidermoid carcinoma of the oral cavity
- stage IV verrucous carcinoma of the oral cavity
- stage I salivary gland cancer
- stage II salivary gland cancer
- Dysgeusia
- Head and Neck Neoplasms
- Radiation Injuries
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