Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053846
Status:
COMPLETED
Last Update Posted:
2015-11-24
First Post:
2003-02-05
Brief Title:
Buspirone in Reducing Shortness of Breath in Patients With Cancer
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Buspirone in Reducing Shortness of Breath in Patients With Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| URCC U1701 | OTHER | University of Rochester | httpsreporternihgovquickSearchU10CA037420 |
| U10CA037420 | NIH | None | None |