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Home > "B" Clinical Trials Conditions > Buspirone in Reducing Shortness of Breath in Patients With Cancer  Buspirone in Reducing Shortness of Breath in Patients With Cancer
Buspirone in Reducing Shortness of Breath in Patients With Cancer
For Condition: Pulmonary Complications,unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Rochester , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 specifed 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 psychotropic medication, including serotonin reuptake inhibitors, or monoamine oxidase inhibitors (MAOIs) - Concurrent narcotic medications allowed - Concurrent benzodiazepine medications allowed - No concurrent psychotropic medication, including serotonin reuptake inhibitors, or MAOIs - No concurrent alcohol
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterBushunow, Study Chair, University of Rochester
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
University of Rochester Cancer Center CCOP Research Base *Recruiting*
Rochester, New York, 14621
United States
Recruiting Peter Bushunow 585-922-4020
Sky Ridge Medical Center *Recruiting*
Lone Tree, Colorado, 80124
United States
Recruiting Dennis Carter 720-225-4211
St. Mary-Corwin Regional Medical Center *Recruiting*
Pueblo, Colorado, 81004
United States
Recruiting Marlow Sloan 719-560-6000
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1461
Porter Adventist Hospital *Recruiting*
Denver, Colorado, 80210
United States
Recruiting David Trevarthen 303-788-8675
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
Longmont United Hospital *Recruiting*
Longmont, Colorado, 80501
United States
Recruiting Robert Fisher 303-485-4132
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Rocky Mountain Cancer Centers *Recruiting*
Thornton, Colorado, 80260
United States
Recruiting Alvin Otsuka 303-386-7622
Penrose Cancer Center *Recruiting*
Colorado Springs, Colorado, 80933
United States
Recruiting Robert Sayre 719-577-2555
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Presbyterian-St Luke's Medical Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Robert Jotte 303-388-4876
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
Boulder Community Hospital *Recruiting*
Boulder, Colorado, 80301-9019
United States
Recruiting John Fleagle 303-440-2399
Rocky Mountain Cancer Centers - Rose *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Scot Sedlacek 303-321-0302
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Swedish Medical Center *Recruiting*
Englewood, Colorado, 80110
United States
Recruiting Marshall Davis 303-788-5860
St. Joseph Hospital *Recruiting*
Denver, Colorado, 80218-1191
United States
Recruiting Michael McLaughlin 303-861-3302
Medical Center of Aurora - South Campus *Recruiting*
Aurora, Colorado, 80012-0000
United States
Recruiting Sami Diab 303-418-7600
Additional Information:
Study ID Numbers: CDR0000269487; URCC-U1701
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053846
Other Pulmonary Complications Studies:
1. 10-Propargyl-10-Deazaaminopterin Plus Probenecid in Treating Patients With Advanced Solid Tumors
2. EF5 in Treating Patients With Solid Tumors
3. Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
4. Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer
5. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Related Studies:
Other Pulmonary Complications Clinical Trials
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Buspirone in Reducing Shortness of Breath in Patients With Cancer
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