Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112749
Status:
TERMINATED
Last Update Posted:
2020-07-31
First Post:
2005-06-02
Brief Title:
Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment stopped due to slow accrual and lack of evidence of need for further continuation of protocol in inpatient setting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Infliximab may help improve energy levels in patients who have undergone treatment for breast cancer
PURPOSE This phase II trial is studying how well infliximab works in treating cancer-related fatigue in postmenopausal women who have undergone treatment for stage 0 stage I or stage II breast cancer
PURPOSE This phase II trial is studying how well infliximab works in treating cancer-related fatigue in postmenopausal women who have undergone treatment for stage 0 stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Determine the association between the bodys immune system and energy sleep mood and other symptoms in postmenopausal women who have undergone treatment for stage 0-II breast cancer
Determine whether treatment with infliximab affects energy and immune function in these patients
OUTLINE Patients receive infliximab IV over 2 hours
Patients complete a diary twice daily for 14 days before and for 14 days after infliximab administration to assess fatigue and other symptoms including mood pain and sleep
After completion of study treatment patients are followed at 2 weeks and then monthly for 3 months
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Determine the association between the bodys immune system and energy sleep mood and other symptoms in postmenopausal women who have undergone treatment for stage 0-II breast cancer
Determine whether treatment with infliximab affects energy and immune function in these patients
OUTLINE Patients receive infliximab IV over 2 hours
Patients complete a diary twice daily for 14 days before and for 14 days after infliximab administration to assess fatigue and other symptoms including mood pain and sleep
After completion of study treatment patients are followed at 2 weeks and then monthly for 3 months
PROJECTED ACCRUAL A total of 10 patients 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 |
|---|---|---|---|
| UCLA-0410033-01 | None | None | None |