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Buspirone in Reducing Shortness of Breath in Patients With Cancer

Primary Purpose

Dyspnea, Pulmonary Complications, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
buspirone hydrochloride
Placebo
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyspnea focused on measuring dyspnea, pulmonary complications, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MBCCOP - University of Illinois at Chicago
  • CCOP - Central Illinois
  • CCOP - Evanston
  • CCOP - Wichita
  • CCOP - Kalamazoo
  • CCOP - Kansas City
  • CCOP - Nevada Cancer Research Foundation
  • CCOP - Hematology-Oncology Associates of Central New York
  • CCOP - Southeast Cancer Control Consortium
  • CCOP - Dayton
  • CCOP - Columbia River Oncology Program
  • CCOP - Greenville
  • CCOP - Upstate Carolina
  • CCOP - Northwest
  • CCOP - Marshfield Clinic Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

buspirone hydrochloride

Placebo

Arm Description

buspirone hydrochloride

Placebo

Outcomes

Primary Outcome Measures

Dyspnea as Measured by Oxygen Cost Diagram (OCD)
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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
October 27, 2015
Sponsor
University of Rochester
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00053846
Brief Title
Buspirone in Reducing Shortness of Breath in Patients With Cancer
Official Title
Buspirone in Reducing Shortness of Breath in Patients With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Pulmonary Complications, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
dyspnea, pulmonary complications, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
buspirone hydrochloride
Arm Type
Experimental
Arm Description
buspirone hydrochloride
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
buspirone hydrochloride
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Dyspnea as Measured by Oxygen Cost Diagram (OCD)
Description
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.
Time Frame
28 days after beginning study drug or placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Bushunow, MD
Organizational Affiliation
University of Rochester
Official's Role
Study Chair
Facility Information:
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7323
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

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Buspirone in Reducing Shortness of Breath in Patients With Cancer

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