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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 173
- 主要终点
- Prolongation of the time to onset of altered taste by zinc sulfate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status:
- •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)
- •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:
- •No prior surgery that included ablation or removal of the olfactory component of taste
- •No concurrent zinc supplements
- •Concurrent standard multivitamins allowed
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: placebo (Other)
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.
干预措施: zinc sulfate (Dietary Supplement)
结局指标
主要结局
Prolongation of the time to onset of altered taste by zinc sulfate
时间窗: Up to 1.5 years
次要结局
- Incidence of taste alteration(Up to 1.5 years)