Buspirone in Reducing Shortness of Breath in Patients With Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Buspirone in Reducing Shortness of Breath in Patients With Cancer

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

Intervention / Treatment
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* Drug: buspirone hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: buspirone hydrochloride<br>buspirone hydrochloride | Drug: buspirone hydrochloride<br>* 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<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea as Measured by Oxygen Cost Diagram (OCD) | OCD was used to evaluate dyspnea on exertion and activities of daily living. OCD is a visual analog scale for quantifying a patient's evaluation of tolerance of exertion, which corresponds to oxygen requirements at different activity levels. It is measured as a score of 2 (sleeping) to 14 (brisk walking uphill). HIgher scores indicate fewer limitations due to dyspnea. | 28 days after beginning study drug or placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyspnea, pulmonary complications, unspecified adult solid tumor, protocol specific