Dyspnea In Cancer Patients
- 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
- Investigate interrelationships of fatigue, depression, anxiety, and patient report of
- 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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
28 days after beginning study drug or placebo
Peter Bushunow, MD
University of Rochester
United States: Federal Government
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - Greenville||Greenville, South Carolina 29615|
|MBCCOP - University of Illinois at Chicago||Chicago, Illinois 60612|
|CCOP - Evanston||Evanston, Illinois 60201|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|CCOP - Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|
|CCOP - Nevada Cancer Research Foundation||Las Vegas, Nevada 89109-2306|