Buspirone in Reducing Shortness of Breath in Patients With Cancer
NCT ID: NCT00053846
Last Updated: 2015-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
432 participants
INTERVENTIONAL
2002-11-30
2011-01-31
Brief Summary
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PURPOSE: Randomized clinical trial to study the effectiveness of buspirone in reducing shortness of breath in patients who are undergoing chemotherapy for cancer.
Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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buspirone hydrochloride
buspirone hydrochloride
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
Placebo
Placebo
Placebo
Placebo
Interventions
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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
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester
OTHER
Responsible Party
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Gary Morrow
Director, URCC CCOP Research Base
Principal Investigators
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Peter Bushunow, MD
Role: STUDY_CHAIR
University of Rochester
Locations
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MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
CCOP - Dayton
Dayton, Ohio, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
CCOP - Northwest
Tacoma, Washington, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Countries
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Other Identifiers
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URCC U1701
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000269487
Identifier Type: -
Identifier Source: org_study_id