View Clinical Trial (Medical Research Study)
Vitamin D and Breast Cancer: Does Weight Make a Difference?
| City: |
|
Stanford |
| State: |
|
California |
| Zip Code: |
|
94305 |
| Conditions: |
|
Breast Cancer |
| Purpose: |
|
This protocol is a randomized, controlled and blinded clinical trial in obese and non-obese
subjects diagnosed with breast cancer in whom we will test the effects of vitamin D
supplementation in the neoadjuvant setting and evaluate changes in biomarker expression in
blood and tissue comparing core breast biopsy to definitive surgical samples. Our goal is to
determine whether dietary vitamin D can reverse the negative effects of obesity and insulin
resistance as reflected by favorable changes in the gene expression patterns in the
pathologic specimens as well as in serum biomarkers of insulin resistance and adipokine
secretion. We expect that vitamin D administration will improve the breast cancer gene
expression pattern from a high-risk configuration to a low-risk profile in the obese
patients and will also cause improvement in the non-obese.
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- 3.1.1 Women who have undergone a core needle biopsy demonstrating an operable breast
cancer whom have not yet had any further therapy.
- 3.1.2 No prior therapy for breast cancer.
- 3.1.4 Age 18 years or older.
- 3.1.5 Any menopausal status
- 3.1.6 Planned surgical resection of breast cancer or repeat core biopsy tissue
sampling prior to initiation of neoadjuvant systemic chemotherapy.
- 3.1.7 Availability of tissue blocks from initial core needle biopsy.
- 3.1.8 Signed informed consent.
- 3.1.9 Willing to discontinue use of all supplements containing Vitamin D for the
duration of the study, and take only the Vitamin D provided by the study.
Exclusion Criteria:
- 3.2.1 Presence of any Metastatic lesion.
- 3.2.2 History of parathyroid disease, hypercalcemia, or kidney stones.
- 3.2.3 History of SERM or aromatase inhibitor therapy.
- 3.2.4 Taking metformin.
- 3.2.5 History of renal failure requiring dialysis or kidney transplantation.
- 3.2.6 Women who are known to be pregnant or who are nursing. (As vitamin D does not
have toxicity to the fetus, a negative pregnancy test is not a requirement to
participate in the study.)
- 3.2.7 Patients planned for surgical therapy of their breast cancer or initiation of
systemic chemotherapy, that would not allow for at least 7 days of vitamin D
intervention
- 3.2.8 Patients with locally advanced breast cancer.
- 3.2.9 Any condition potentially interfering with subjects ability to comply with
taking study medication.
- 3.2.10 Any medical condition that would potentially interfere with vitamin D
absorption.
- 3.2.11 Current participation in another research study that would increase risk to
subject, in the opinion of the investigators.
- 3.2.12 Patients currently taking more than 2000 IU of Vitamin D.
|
| NCT ID: |
|
NCT01472445 |
| Primary Contact: |
|
Principal Investigator
Melinda Telli, MD
Stanford University
Annabel Castaneda
Phone: 650-498-7977
Email: annabelc@stanford.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Stanford, California 94305
United States
Stanford Cancer Clinical Trials Office
Phone: 650-498-7061
Email: ccto-office@stanford.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 23, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|