Buspirone in Reducing Shortness of Breath in Patients With Cancer
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
-
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Illinois
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Chicago、Illinois、美国、60612-7323
- MBCCOP - University of Illinois at Chicago
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Decatur、Illinois、美国、62526
- CCOP - Central Illinois
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Evanston、Illinois、美国、60201
- CCOP - Evanston
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Kansas
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Wichita、Kansas、美国、67214-3882
- CCOP - Wichita
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Michigan
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Kalamazoo、Michigan、美国、49007-3731
- CCOP - Kalamazoo
-
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Missouri
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Kansas City、Missouri、美国、64131
- CCOP - Kansas City
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Nevada
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Las Vegas、Nevada、美国、89106
- CCOP - Nevada Cancer Research Foundation
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New York
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East Syracuse、New York、美国、13057
- CCOP - Hematology-Oncology Associates of Central New York
-
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North Carolina
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Goldsboro、North Carolina、美国、27534-9479
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Dayton、Ohio、美国、45429
- CCOP - Dayton
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Oregon
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Portland、Oregon、美国、97225
- CCOP - Columbia River Oncology Program
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South Carolina
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Greenville、South Carolina、美国、29615
- CCOP - Greenville
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Spartanburg、South Carolina、美国、29303
- CCOP - Upstate Carolina
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Washington
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Tacoma、Washington、美国、98405-0986
- CCOP - Northwest
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Wisconsin
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Marshfield、Wisconsin、美国、54449
- CCOP - Marshfield Clinic Research Foundation
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
Treatment includes the following scenarios:
- May have had prior chemotherapy course(s)
Scheduled to receive at least 2 courses of chemotherapy
- Courses may include multiple treatment days such as days 1-5 or day 1-day 8 regimens and may include oral regimens
Dyspnea as a symptom within the past 5 days (defined by a score of at least grade 2 on the Modified Medical Research Council Dyspnea Scale)
- All underlying causes of dyspnea have received medical treatment per best clinical judgement of treating physician
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Eastern Cooperative Oncology Group 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Adequate hepatic function (determined by treating oncologist)
Renal
- Adequate renal function (determined by treating oncologist)
Cardiovascular
- Adequate cardiac function (determined by treating oncologist)
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of mania or seizures
- No prior hospitalization for any psychiatric condition
- No prior hypersensitivity to buspirone
- Able to swallow medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Concurrent radiotherapy allowed
Surgery
- Not specified
Other
- At least 2 weeks since prior and no concurrent monoamine oxidase inhibitors (MAOIs)
- Concurrent narcotic medications allowed
- Concurrent benzodiazepine medications allowed
- Concurrent serotonin reuptake inhibitors allowed
- No concurrent alcohol
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
安慰剂
|
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实验性的：buspirone hydrochloride
|
The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dyspnea as Measured by Oxygen Cost Diagram (OCD)
大体时间：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.
|
28 days after beginning study drug or placebo
|
合作者和调查者
调查人员
- 学习椅：Peter Bushunow, MD、University of Rochester
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的