Conditions: Dyspnea Pulmonary Complications Unspecified Adult Solid Tumor, Protocol Specific
Keywords: dyspnea pulmonary complications unspecified adult solid tumor, protocol specific
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 432
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: buspirone hydrochloride arm 2: Placebo

Interventions: intervention 1: buspirone hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period intervention 2: Placebo

Protocol document: