Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416715
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2006-12-27
Brief Title:
Vitamin D Deficiency Muscle Pain Joint Pain and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Pilot Study of Vitamin D Deficiency and Myalgias Arthralgias andor Joint Stiffness Associated With Letrozole Femara
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This phase II trial is studying vitamin D deficiency muscle pain joint pain and joint stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer Learning about vitamin D deficiency and muscle pain joint pain and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably
Detailed Description:
PRIMARY OBJECTIVES
I To assess the rate of vitamin D deficiency in breast cancer patients who experience myalgias arthralgias andor joint stiffness following initiation of adjuvant letrozole treatment
SECONDARY OBJECTIVES
I To determine if there is a correlation between letrozole serum levels and the development of myalgias arthralgias andor joint stiffness
II To assess if vitamin D supplementation may alleviate myalgias arthralgias andor joint stiffness associated with letrozole in those subjects with vitamin D deficiency
OUTLINE
Patients receive letrozole orally PO once daily QD Patients who experience muscle pain joint pain or joint stiffness that requires an intervention and who are found to be vitamin D deficient also receive calcium PO and vitamin D3 PO Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity
I To assess the rate of vitamin D deficiency in breast cancer patients who experience myalgias arthralgias andor joint stiffness following initiation of adjuvant letrozole treatment
SECONDARY OBJECTIVES
I To determine if there is a correlation between letrozole serum levels and the development of myalgias arthralgias andor joint stiffness
II To assess if vitamin D supplementation may alleviate myalgias arthralgias andor joint stiffness associated with letrozole in those subjects with vitamin D deficiency
OUTLINE
Patients receive letrozole orally PO once daily QD Patients who experience muscle pain joint pain or joint stiffness that requires an intervention and who are found to be vitamin D deficient also receive calcium PO and vitamin D3 PO Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| NCI-2010-00621 | REGISTRY | CTRP Clinical Trial Reporting Program | None |