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Buspirone in Reducing Shortness of Breath in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053846
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : March 20, 2015
Last Update Posted : November 24, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Dyspnea Pulmonary Complications Unspecified Adult Solid Tumor, Protocol Specific Drug: buspirone hydrochloride Drug: Placebo Phase 2 Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Buspirone in Reducing Shortness of Breath in Patients With Cancer
Study Start Date : November 2002
Actual Primary Completion Date : November 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: buspirone hydrochloride
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

Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Eastern Cooperative Oncology Group 0-2

Life expectancy

  • Not specified


  • Not specified


  • Adequate hepatic function (determined by treating oncologist)


  • Adequate renal function (determined by treating oncologist)


  • Adequate cardiac function (determined by treating oncologist)


  • 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


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • Concurrent radiotherapy allowed


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053846

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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)
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Study Chair: Peter Bushunow, MD University of Rochester
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Responsible Party: Gary Morrow, Director, URCC CCOP Research Base, University of Rochester Identifier: NCT00053846    
Other Study ID Numbers: CDR0000269487
U10CA037420 ( U.S. NIH Grant/Contract )
URCC U1701 ( Other Identifier: University of Rochester )
First Posted: February 6, 2003    Key Record Dates
Results First Posted: March 20, 2015
Last Update Posted: November 24, 2015
Last Verified: October 2015
Keywords provided by Gary Morrow, University of Rochester:
pulmonary complications
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action