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NCT Number: NCT00053846

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.

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Key information

Conditions

Dyspnea Pathological Conditions, Signs and Symptoms Pulmonary Complications Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buspirone hydrochloride

Drug

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

Placebo

Drug

Placebo

Primary outcomes

Dyspnea as Measured by Oxygen Cost Diagram (OCD)

Time frame: 28 days after beginning study drug or placebo

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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2002
Primary completion: 2010
Study completion: 2011
First posted: Feb 6, 2003
Registry last updated: Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed