Buspirone in Reducing Shortness of Breath in Patients With Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of Rochester
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00053846
First received: February 5, 2003
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dyspnea Pulmonary Complications Unspecified Adult Solid Tumor, Protocol Specific |
Drug: buspirone hydrochloride |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Supportive Care |
| Official Title: | Dyspnea In Cancer Patients |
Resource links provided by NLM:
Further study details as provided by University of Rochester:
Primary Outcome Measures:
- dyspnea [ Time Frame: 28 days after beginning study drug or placebo ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 376 |
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: buspirone hydrochloride |
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053846
Locations
| United States, Illinois | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New York | |
| CCOP - Hematology-Oncology Associates of Central New York | |
| East Syracuse, New York, United States, 13057 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| United States, Ohio | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
Sponsors and Collaborators
University of Rochester
Investigators
| Study Chair: | Peter Bushunow, MD | University of Rochester |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00053846 History of Changes |
| Other Study ID Numbers: | CDR0000269487, U10CA037420, URCC-U1701 |
| Study First Received: | February 5, 2003 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Rochester:
|
dyspnea pulmonary complications unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Dyspnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Buspirone Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013