Buspirone in Reducing Shortness of Breath in Patients With Cancer

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

• NCT number: NCT00053846
• Study type: Interventional
• Source: University of Rochester
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2002
• Completion date: January 2011