NCT00017511已完成3 期
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Cevimeline in the Treatment of Xerostomia Secondary to Radiation Therapy for Cancer in the Head and Neck Region
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 71
研究概览
简要总结
RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no therapy in treating dry mouth caused by radiation therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.
详细描述
OBJECTIVES:
- Compare the efficacy of cevimeline vs placebo, in terms of dryness of the oral cavity and salivary flow, in patients with xerostomia secondary to radiotherapy for cancers in the head and neck region.
- Assess the safety of this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral cevimeline 3 times daily for 12 weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo as in arm I.
PROJECTED ACCRUAL: A total of 280 patients (140 per arm) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
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:
- •Received more than 4,000 cGy of prior external beam radiotherapy for cancer in the head and neck region
- •Radiotherapy completed more than 4 months prior to study
- •Clinically significant salivary gland dysfunction with grade 2 or 3 xerostomia
- •At least 1 anatomically intact parotid gland
- •No suspected or confirmed bilateral physical closure of salivary gland ducts
- •No history of primary or secondary Sjogren's syndrome or other underlying systemic illness known to cause xerostomia independent of prior radiotherapy exposure
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •Hemoglobin at least 9.0 g/dL
- •No anemia
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •SGOT/SGPT no greater than 2 times ULN
- •Lactate dehydrogenase no greater than 2 times ULN
- •No evidence of active liver disease
- •Creatinine no greater than 2.5 mg/dL
- •BUN no greater than 50 mg/dL
- •No history of nephrolithiasis within the past 6 months
- •Cardiovascular:
- •No history of significant cardiovascular disease
- •No active congestive heart failure
- •No uncontrolled angina
- •No significant arrhythmia
- •No myocardial infarction within the past 6 months
- •No history of significant pulmonary disease
- •No controlled or uncontrolled asthma
- •No chronic bronchitis or chronic obstructive pulmonary disease that would limit avocational activities
- •Gastrointestinal:
- •No history of significant gastrointestinal disorder
- •No active pancreatic disease
- •No gastroduodenal ulcers within the past 6 months
- •No hypersensitive bowel conditions requiring pharmacologic therapy
- •No inflammatory bowel disease
- •No history of cholelithiasis within the past 6 months (unless cholecystectomy performed)
- •No clinically significant laboratory abnormality
- •No history of alcohol or drug abuse within the past 6 months that would preclude study
- •No prior or concurrent acute iritis or narrow-angle (angle closure) glaucoma
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No concurrent chemotherapy
- 另有 12 项未显示
排除标准
- 未提供
研究者
研究点 (71)
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