Official Title: “Dyspnea In Cancer Patients”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: buspirone hydrochloride

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 specifed
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Rochester

Overall Clinical Trial Officials and Contacts

Peter Bushunow, MD Study Chair University of Rochester  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00053846

Study ID Number: CDR0000269487

ClinicalTrials.gov Identifier: NCT00053846

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database