Vitamin D and Breast Cancer: Does Weight Make a Difference?
Trial ID or NCT#
NCT01472445
Status
NOT RECRUITING
Purpose
This is a research study of the effect of Vitamin D on breast cancer. We hope to learn whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that affect its growth. We believe some of these characteristics may be influenced by body weight.
Official Title
Vitamin D and Breast Cancer: Does Weight Make a Difference?
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy. - No prior therapy for breast cancer. - Age 18 years or older. - Any menopausal status - Planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy. - Availability of tissue blocks from initial core needle biopsy. - Signed informed consent. - 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:
- - Presence of any Metastatic lesion. - History of parathyroid disease, hypercalcemia, or kidney stones. - History of Selective estrogen receptor modulator (SERM) or aromatase inhibitor therapy. - Receiving metformin. - History of renal failure requiring dialysis or kidney transplantation. - 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.) - 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 - Any condition potentially interfering with subjects ability to comply with taking study medication. - Any medical condition that would potentially interfere with vitamin D absorption. - Current participation in another research study that would increase risk to subject, in the opinion of the investigators. - Patients currently taking more than 2000 IU of Vitamin D.
Investigator(s)
Kristin Jensen
David Feldman
Robert W. Carlson
Contact us to find out if this trial is right for you.
Contact
ccto-office@stanford.edu
650-498-7061
View on ClinicalTrials.gov
