Buspirone in Reducing Shortness of Breath in Patients With Cancer

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: National Cancer Institute (NCI)
• Treatments: Buspirone

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

• Eastern Cooperative Oncology Group 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