Buspirone in Reducing Shortness of Breath in Patients With Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 432
- 试验地点
- 15
- 主要终点
- Dyspnea as Measured by Oxygen Cost Diagram (OCD)
研究概览
简要总结
RATIONALE: Buspirone may be effective in reducing dyspnea (shortness of breath) in patients with cancer who are undergoing chemotherapy.
PURPOSE: Randomized clinical trial to study the effectiveness of buspirone in reducing shortness of breath in patients who are undergoing chemotherapy for cancer.
详细描述
OBJECTIVES:
- Assess the degree to which buspirone can decrease the sensation of dyspnea in patients with malignant disease.
- Estimate the incidence of dyspnea in patients seen in community oncology practice settings.
- Investigate interrelationships of fatigue, depression, anxiety, and patient report of dyspnea.
- Assess the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center (CCOP site). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning on day 7 of chemotherapy, patients receive oral buspirone once a day for 3 days and then twice daily for up to 28 days.
- Arm II: Patients receive oral placebo as in arm I. Dyspnea is assessed at baseline. Dyspnea, mood, fatigue, depression, anxiety, and quality of life are assessed within 5-7 days before chemotherapy and immediately following therapy.
PROJECTED ACCRUAL: A total of 376 patients (188 per treatment arm) will be accrued for this study.
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, Care Provider)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
buspirone hydrochloride
buspirone hydrochloride
干预措施: buspirone hydrochloride (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Dyspnea as Measured by Oxygen Cost Diagram (OCD)
时间窗: 28 days after beginning study drug or placebo
OCD was used to evaluate dyspnea on exertion and activities of daily living. OCD is a visual analog scale for quantifying a patient's evaluation of tolerance of exertion, which corresponds to oxygen requirements at different activity levels. It is measured as a score of 2 (sleeping) to 14 (brisk walking uphill). HIgher scores indicate fewer limitations due to dyspnea.
次要结局
未报告次要终点
研究者
Gary Morrow
Director, URCC CCOP Research Base
University of Rochester