Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031811
Status:
COMPLETED
Last Update Posted:
2012-05-28
First Post:
2002-03-08
Brief Title:
Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Breast Cancer Survivors Exercise and Raloxifene
Status:
COMPLETED
Status Verified Date:
2010-06
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 Raloxifene and exercise may improve bone health and quality of life in breast cancer survivors Assessing bone health and quality of life may improve the ability to plan treatment
PURPOSE Randomized clinical trial to study the effectiveness of raloxifene with or without exercise compared with exercise alone in women who have been previously treated for breast cancer
PURPOSE Randomized clinical trial to study the effectiveness of raloxifene with or without exercise compared with exercise alone in women who have been previously treated for breast cancer
Detailed Description:
OBJECTIVES
Determine the effects of raloxifene with or without exercise versus exercise alone on bone reabsorption rate bone formation rate and bone density in women previously treated for breast cancer
Determine the effects of these regimens on the quality of life of these patients
OUTLINE This is a randomized placebo-controlled multicenter study Patients are randomized to one of four treatment arms
Arm I Patients are asked to exercise 5 days a week with instruction Patients also receive oral placebo once daily
Arm II Patients receive oral raloxifene once daily
Arm III Patients are asked to exercise as in arm I Patients also receive oral raloxifene once daily
Arm IV Patients receive oral placebo once daily All patients receive oral calcium supplements once daily Treatment continues in all arms for 24 months in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and every 3 months during study
PROJECTED ACCRUAL A total of 240 patients 60 per treatment arm will be accrued for this study
Determine the effects of raloxifene with or without exercise versus exercise alone on bone reabsorption rate bone formation rate and bone density in women previously treated for breast cancer
Determine the effects of these regimens on the quality of life of these patients
OUTLINE This is a randomized placebo-controlled multicenter study Patients are randomized to one of four treatment arms
Arm I Patients are asked to exercise 5 days a week with instruction Patients also receive oral placebo once daily
Arm II Patients receive oral raloxifene once daily
Arm III Patients are asked to exercise as in arm I Patients also receive oral raloxifene once daily
Arm IV Patients receive oral placebo once daily All patients receive oral calcium supplements once daily Treatment continues in all arms for 24 months in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and every 3 months during study
PROJECTED ACCRUAL A total of 240 patients 60 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 |
|---|---|---|---|
| OHSU-6312 | OTHER | None | None |
| NCI-H02-0086 | Other Identifier | OHSU IRB | None |