Buspirone in Reducing Shortness of Breath in Patients With 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