Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Dyspnea

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Buspirone

Anti-Anxiety Agents

Serotonin

Serotonin Receptor Agonists

Neurotransmitter Agents

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

buspirone hydrochloride

Placebo

Peter Bushunow, MD

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.

Buspirone in Reducing Shortness of Breath in Patients With Cancer

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.

National Cancer Institute (NCI)

University of Rochester

Director, URCC CCOP Research Base

buspirone hydrochloride: 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

Buspirone Hydrochloride

Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

African American

Other

Race/Ethnicity, Customized

Married

Not Married

Marital Status

Beyond High School

High School or Less

Education

History of chronic obstructive pulmonary disease (COPD)

Lung

Breast

Gastrointestinal

Tumor Site

Unknown

Tumor Stage

Oxygen Cost Diagram (OCD) is 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 for exertion. It corresponds to the oxygen requirements at different activity levels. It is presented as a score ranging from 2 (i.e.; even sleeping induces exertion) to 14 (i.e., unable to walk briskly uphill). Higher scores indicate fewer limitations due to dyspnea.

O2 Cost Diagram (OCD)

The Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade is assessed on a 5-point scale with a range of 0 to 4. Grade 0 (I only get breathless with strenuous exercise) to Grade 4 (I am too breathless to leave the house or I am breathless when dressing). Higher scores are less favorable.

Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade

Charles E. Heckler, PhD, MS. Research Assistant Professor

H0: The true difference in means is equal to zero. Ha: The true difference in means is not equal to zero.

Dyspnea as Measured by Oxygen Cost Diagram (OCD)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Buspirone in Reducing Shortness of Breath in Patients With Cancer	NCT00053846	Dyspnea Pulmonary Compl... Unspecified Adu...	buspirone hydro... Placebo	18 Years - 120 Years	University of Rochester
Buspirone in Reducing Shortness of Breath in Patients With Cancer	NCT00053846	Dyspnea Pulmonary Compl... Unspecified Adu...	buspirone hydro... Placebo	18 Years - 120 Years	University of Rochester

Spots Global Cancer Trial Database for buspirone hydrochloride