Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
NCT00416715 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2017-07-11
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
Conditions
- Arthralgia
- Musculoskeletal Complications
- Pain
- Recurrent Breast Cancer
- Stage I Breast Cancer
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
Interventions
- DRUG
-
Given PO
- DIETARY_SUPPLEMENT
-
calcium carbonate
Given PO
- OTHER
-
laboratory biomarker analysis
Optional correlative studies
- DIETARY_SUPPLEMENT
-
calcium citrate
Given PO
- DIETARY_SUPPLEMENT
-
calcium glucarate
Given PO
- DRUG
-
calcium gluconate
Given PO
- DIETARY_SUPPLEMENT
-
cholecalciferol
Given PO
- PROCEDURE
-
assessment of therapy complications
Ancillary studies
- PROCEDURE
-
musculoskeletal complications management/prevention
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Hannah Linden · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-10-31
- Primary Completion
- 2010-05-31
- Completion
- 2010-05-31
Countries
- United States
Study Locations
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