Buspirone in Reducing Shortness of Breath in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT00053846|
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : March 20, 2015
Last Update Posted : November 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Dyspnea Pulmonary Complications Unspecified Adult Solid Tumor, Protocol Specific||Drug: buspirone hydrochloride Drug: Placebo||Phase 2 Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||432 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Buspirone in Reducing Shortness of Breath in Patients With Cancer|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||January 2011|
Experimental: buspirone hydrochloride
Drug: 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 Comparator: Placebo
- Dyspnea as Measured by Oxygen Cost Diagram (OCD) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053846
|United States, Illinois|
|MBCCOP - University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612-7323|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|CCOP - Evanston|
|Evanston, Illinois, United States, 60201|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Michigan|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, Missouri|
|CCOP - Kansas City|
|Kansas City, Missouri, United States, 64131|
|United States, Nevada|
|CCOP - Nevada Cancer Research Foundation|
|Las Vegas, Nevada, United States, 89106|
|United States, New York|
|CCOP - Hematology-Oncology Associates of Central New York|
|East Syracuse, New York, United States, 13057|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Goldsboro, North Carolina, United States, 27534-9479|
|United States, Ohio|
|CCOP - Dayton|
|Dayton, Ohio, United States, 45429|
|United States, Oregon|
|CCOP - Columbia River Oncology Program|
|Portland, Oregon, United States, 97225|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, Washington|
|CCOP - Northwest|
|Tacoma, Washington, United States, 98405-0986|
|United States, Wisconsin|
|CCOP - Marshfield Clinic Research Foundation|
|Marshfield, Wisconsin, United States, 54449|
|Study Chair:||Peter Bushunow, MD||University of Rochester|