buspirone in reducing shortness of breath in patients with cancer

Conditions: Dyspnea; Pulmonary Complications; Unspecified Adult Solid Tumor, Protocol Specific

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.

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 * 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

Keywords: dyspnea pulmonary complications unspecified adult solid tumor, protocol specific