NCT00053846

Buspirone in Reducing Shortness of Breath in Patients With Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyspnea
• Pulmonary Complications
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
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
DRUG	Placebo	Placebo

Timeline

• Start date: 2002-11-01
• Primary completion: 2010-11-01
• Completion: 2011-01-01
• First posted: 2003-02-06
• Last updated: 2015-11-24
• Results posted: 2015-03-20

Locations

15 sites across 1 country: United States