Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
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