Buspirone in Reducing Shortness of Breath in Patients With Cancer
Buspirone in Reducing Shortness of Breath in Patients With Cancer
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.
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.
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