Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Buspirone in Reducing Shortness of Breath in Patients With Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Active	18 and over	NCI	URCC-U1701 NCT00053846

Objectives

1. Assess the degree to which buspirone can decrease the sensation of dyspnea in patients with malignant disease.
2. Estimate the incidence of dyspnea in patients seen in community oncology practice settings.
3. Investigate interrelationships of fatigue, depression, anxiety, and patient report of dyspnea.
4. Assess the quality of life of patients treated with this drug.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specifed

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

Expected Enrollment

A total of 376 patients (188 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

University of Rochester Cancer Center CCOP Research Base

Peter Bushunow, MD, Protocol chair		Ph: 585-922-4020

U.S.A.
Illinois
	Chicago
	MBCCOP - University of Illinois at Chicago
		Judith Murray	Ph:  312-355-1472
			Email: memurray@uic.edu
	Decatur
	CCOP - Central Illinois
		James Wade, MD	Ph:  217-876-6617
			Email: jlwade3@sbcglobal.net
	Evanston
	CCOP - Evanston
		David Grinblatt, MD	Ph:  847-570-2109
Kansas
	Wichita
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-268-5784 800-362-5784
Michigan
	Kalamazoo
	CCOP - Kalamazoo
		Raymond Lord, MD	Ph:  269-373-7458
			Email: rlord@wmcc.org
Missouri
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
			Email: rgaur@saint-lukes.org
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
			Email: k.vanwagenen@sncrf.org
New York
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
			Email: jkirshner@hoacny.com
North Carolina
	Goldsboro
	CCOP - Southeast Cancer Control Consortium
		James Atkins, MD	Ph:  336-777-3036
Ohio
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-395-8678
Oregon
	Portland
	CCOP - Columbia River Oncology Program
		Keith Lanier, MD	Ph:  503-216-6262
South Carolina
	Greenville
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-241-6251
	Spartanburg
	CCOP - Upstate Carolina
		Clinical Trials Office - CCOP - Upstate Carolina	Ph:  800-486-5941
Washington
	Tacoma
	CCOP - Northwest
		Lauren Colman, MD	Ph:  253-403-1461
			Email: lauren.colman@multicare.org
Wisconsin
	Marshfield
	CCOP - Marshfield Clinic Research Foundation
		Clinical Trials Office - CCOP - Marshfield Clinic Research Foundation	Ph:  715-389-4457

Registry Information
Official Title		Dyspnea In Cancer Patients
Trial Start Date		2002-11-20
Trial Completion Date		2008-12-01 (estimated)
Registered in ClinicalTrials.gov		NCT00053846
Date Submitted to PDQ		2002-12-03
Information Last Verified		2009-06-14
NCI Grant/Contract Number		CA037420

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