Dyspnea In Cancer Patients
18 Years
N/A
Both
Dyspnea, Pulmonary Complications, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Dyspnea In Cancer Patients
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.
Inclusion 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
- ECOG 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Outcome Measure:
dyspnea
Outcome Time Frame:
28 days after beginning study drug or placebo
Safety Issue:
No
Principal Investigator
Peter Bushunow, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Rochester
Authority:
United States: Federal Government
Study ID:
CDR0000269487
NCT ID:
NCT00053846
Start Date:
November 2002
Completion Date:
October 2013
Related Keywords:
- Dyspnea
- Pulmonary Complications
- Unspecified Adult Solid Tumor, Protocol Specific
- dyspnea
- pulmonary complications
- unspecified adult solid tumor, protocol specific
- Dyspnea
Name | Location |
|---|---|
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
| CCOP - Evanston | Evanston, Illinois 60201 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
