Clinical trial NCT00053846: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dyspnea
Pulmonary Complications
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: dyspnea
pulmonary complications
unspecified adult solid tumor, protocol specific
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-02-06
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Dyspnea as Measured by Oxygen Cost Diagram (OCD)
timeFrame: 28 days after beginning study drug or placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: MBCCOP - University of Illinois at Chicago
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Evanston
country: United States
facility: CCOP - Evanston
state: Illinois
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Las Vegas
country: United States
facility: CCOP - Nevada Cancer Research Foundation
state: Nevada
city: East Syracuse
country: United States
facility: CCOP - Hematology-Oncology Associates of Central New York
state: New York
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Dayton
country: United States
facility: CCOP - Dayton
state: Ohio
city: Portland
country: United States
facility: CCOP - Columbia River Oncology Program
state: Oregon
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Tacoma
country: United States
facility: CCOP - Northwest
state: Washington
city: Marshfield
country: United States
facility: CCOP - Marshfield Clinic Research Foundation
state: Wisconsin
Study officials:
affiliation: University of Rochester
name: Peter Bushunow, MD
role: STUDY_CHAIR
References: