Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer

• Treatment includes the following scenarios:

• May have had prior chemotherapy course(s)

• Scheduled to receive at least 2 courses of chemotherapy

• Courses may include multiple treatment days such as days 1-5 or day 1-day 8 regimens and may include oral regimens

• Dyspnea as a symptom within the past 5 days (defined by a score of at least grade 2 on the Modified Medical Research Council Dyspnea Scale)

• All underlying causes of dyspnea have received medical treatment per best clinical judgement of treating physician

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Adequate hepatic function (determined by treating oncologist)

Renal

• Adequate renal function (determined by treating oncologist)

Cardiovascular

• Adequate cardiac function (determined by treating oncologist)

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No history of mania or seizures

• No prior hospitalization for any psychiatric condition

• No prior hypersensitivity to buspirone

• Able to swallow medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Concurrent radiotherapy allowed

Surgery

• Not specified

Other

• At least 2 weeks since prior and no concurrent monoamine oxidase inhibitors (MAOIs)

• Concurrent narcotic medications allowed

• Concurrent benzodiazepine medications allowed

• Concurrent serotonin reuptake inhibitors allowed

• No concurrent alcohol

Trial Contact Information

Trial Lead Organizations/Sponsors

James P. Wilmot Cancer Center at University of Rochester Medical Center

Peter Bushunow

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00053846
Information obtained from ClinicalTrials.gov on December 14, 2011

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