NCT00020657已完成3 期
Treatment of Delayed Nausea: What Works Best?
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Gary Morrow
- 试验地点
- 15
研究概览
简要总结
RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy.
PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
详细描述
OBJECTIVES:
- Compare the effectiveness of a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer.
- Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients.
- Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine.
- Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.
Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) combined with dexamethasone on day 1.
Patients are then randomized to 1 of 3 antiemetic arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of cancer for which a chemotherapy regimen containing doxorubicin (with adjuvant, neoadjuvant, curative, or palliative intent) is scheduled
- •Scheduled chemotherapy regimen must not include any of the following:
- •Multiple doses of doxorubicin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin
- •Doxorubicin HydroCloride liposome or cisplatin
- •Scheduled chemotherapy regimen may contain agents, other than those listed above, administered orally, IV, or IV continuously on 1 or multiple days
- •Must be scheduled to receive a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone concurrently with doxorubicin
- •No clinical evidence of an impending bowel obstruction
- •No symptomatic brain metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent interferon
- •Chemotherapy:
- •See Disease Characteristics
- •No prior chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •Radiotherapy:
- •No concurrent radiotherapy
- •Not specified
- •Concurrent rescue medications (as appropriate) for control of symptoms caused by cancer or its treatment allowed
排除标准
- 未提供
研究者
Gary Morrow
Director, University of Rochester NCORP Research Base
University of Rochester NCORP Research Base
研究点 (15)
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