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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA037420 | U.S. NIH Grant/Contract | View source | |
| URCC U1701 | Other Identifier | University of Rochester |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 376 patients (188 per treatment arm) will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| buspirone hydrochloride | Experimental | buspirone hydrochloride |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buspirone hydrochloride | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bushunow, MD | University of Rochester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - University of Illinois at Chicago | Chicago | Illinois | 60612-7323 | United States | ||
| CCOP - Central Illinois |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buspirone Hydrochloride | 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 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo |
|
| Decatur |
| Illinois |
| 62526 |
| United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| CCOP - Southeast Cancer Control Consortium | Goldsboro | North Carolina | 27534-9479 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Buspirone Hydrochloride | 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 |
| BG001 | Placebo | Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Marital Status | Number | participants |
| ||||||||||||||||
| Education | Number | participants |
| ||||||||||||||||
| History of chronic obstructive pulmonary disease (COPD) | Number | participants |
| ||||||||||||||||
| Tumor Site | Number | participants |
| ||||||||||||||||
| Tumor Stage | Number | participants |
| ||||||||||||||||
| O2 Cost Diagram (OCD) | Oxygen Cost Diagram (OCD) is 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 for exertion. It corresponds to the oxygen requirements at different activity levels. It is presented as a score ranging from 2 (i.e.; even sleeping induces exertion) to 14 (i.e., unable to walk briskly uphill). Higher scores indicate fewer limitations due to dyspnea. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade | The Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade is assessed on a 5-point scale with a range of 0 to 4. Grade 0 (I only get breathless with strenuous exercise) to Grade 4 (I am too breathless to leave the house or I am breathless when dressing). Higher scores are less favorable. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 28 days after beginning study drug or placebo |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buspirone Hydrochloride | 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 | 3 | 213 | 13 | 213 | ||
| EG001 | Placebo | Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period. | 3 | 219 | 10 | 219 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Breathlessness & Chest Pressure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Anemia & pleural effusion, inc SOB | General disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Scrotal pain/swelling; hypoxia; death | General disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness, confusion; insomnia | Nervous system disorders | Systematic Assessment |
| ||
| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aching hands and back | General disorders | Systematic Assessment |
| ||
| Nausea and vomitting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Disease progression | General disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Confusion | Nervous system disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Shakes and tremors | General disorders | Systematic Assessment |
| ||
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pneumonia/bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Low platelet count | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypoxemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Orthostatis hypotension | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles E. Heckler, PhD, MS. Research Assistant Professor | University of Rochester Medical Center | 585-273-1141 | checkler@urmc.rochester.edu |
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002065 | Buspirone |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| African American |
|
| Other |
|
| Not Married |
|
| High School or Less |
|
| No |
|
| Breast |
|
| Gastrointestinal |
|
| Other |
|
| II |
|
| III |
|
| IV |
|
| Unknown |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| Unknown |
|