Status:
TERMINATED
Vitamin D and Breast Cancer: Does Weight Make a Difference?
Lead Sponsor:
Melinda Telli
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Vitamin D3 (cholecalciferol, colecalciferol) is one of type of vitamin D which is made by the skin when exposed to sunlight; it is also found in some foods and can be taken as a dietary supplement. It...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01472445
Start Date
November 1 2011
End Date
October 1 2015
Last Update
April 19 2019
Active Locations (1)
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1
Stanford University Cancer Institute
Stanford, California, United States, 94305