Spots Global Cancer Trial Database for Buspirone in Reducing Shortness of Breath in Patients With Cancer

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Trial Identification

Brief Title: Buspirone in Reducing Shortness of Breath in Patients With Cancer

Official Title: Buspirone in Reducing Shortness of Breath in Patients With Cancer

Study ID: NCT00053846

Conditions

Dyspnea

Pulmonary Complications

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

buspirone hydrochloride

Placebo

Study Description

Brief Summary: 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.

Detailed Description: 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.