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Buspirone in Reducing Shortness of Breath in Patients With Cancer

2014-07-24 14:33:53 | BioPortfolio

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.

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, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Supportive Care

Conditions

Dyspnea

Intervention

buspirone hydrochloride

Location

MBCCOP - University of Illinois at Chicago
Chicago
Illinois
United States
60612-7323

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:33:53-0400

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