Buspirone in Reducing Shortness of Breath in Patients With Cancer - Full Text View

Sponsor:	University of Rochester
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	University of Rochester
ClinicalTrials.gov Identifier:	NCT00053846

Purpose

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.

Condition	Intervention
Dyspnea Pulmonary Complications Unspecified Adult Solid Tumor, Protocol Specific	Drug: buspirone hydrochloride

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Supportive Care
Official Title:	Dyspnea In Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems Cancer

Drug Information available for: Buspirone hydrochloride Buspirone

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

dyspnea [ Time Frame: 28 days after beginning study drug or placebo ] [ Designated as safety issue: No ]

Estimated Enrollment:	376
Study Start Date:	November 2002
Estimated Study Completion Date:	July 2014
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: buspirone hydrochloride	Drug: 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

ECOG 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053846

Locations

United States, Illinois
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Evanston
Evanston, Illinois, United States, 60201
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
United States, Ohio
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449

Sponsors and Collaborators

University of Rochester

National Cancer Institute (NCI)

Investigators

Study Chair:

Peter Bushunow, MD

University of Rochester

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00053846 History of Changes
Other Study ID Numbers:	CDR0000269487, U10CA037420, URCC-U1701
Study First Received:	February 5, 2003
Last Updated:	August 22, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Rochester:

dyspnea
pulmonary complications
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Buspirone
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012