Buspirone in Reducing Shortness of Breath in Patients With Cancer

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Buspirone in Reducing Shortness of Breath in Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053846
• Other study ID #: CDR0000269487
• Secondary ID: U10CA037420URCC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 5, 2003
• Last updated: October 27, 2015
• Start date: November 2002
• Est. completion date: January 2011

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

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
Placebo

Locations

Country	Name	City	State
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days after beginning study drug or placebo	No