Status:
COMPLETED
Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D)
Lead Sponsor:
Loyola University
Conditions:
Adult Women
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Background: Several clinical trials are underway to investigate if variable forms of vitamin D (D2 vs. D3) prescribed at different doses (10,000-50,000 IUs/week) can improve the side-effects associate...
Detailed Description
Study Aims Several clinical trials are underway to investigate if vitamin D2 or D3 provided at various doses (10,000-50,000 IUs/week) can improve the side-effects associated with anti-estrogen therap...
Eligibility Criteria
Inclusion
- Metastatic breast cancer (Stage IV)
- Histologically confirmed estrogen receptor positive disease
- Female
- Serum 25(OH) \<30 ng/ml
- Age ≥ 18 years
- Pre or post-menopausal
- ECOG Performance status 0-2
- Adequate organ function as defined as GFR\> 30 mls/min and serum calcium ≤ 10.4 mg/dl
- Any race/ethnicity
- English speaking
- No changes to MBC treatments within 30 days of enrollment and/or deemed clinically stable by their treating physician
- Willingness to sign a written informed consent and complete questionnaires
- Cease ingestion of vitamin D supplementation not study related
Exclusion
- Women with Stage I-III breast cancer
- Serum 25(OH)D levels ≥ 30 ng/ml
- Untreated CNS involvement
- History of kidney stones
- History of renal failure
- History of hyperparathyroidism
- History of hypersensitivity to vitamin D
- Non-English speaking
- Currently pregnant or lactating, or anticipating pregnancy
- Unwilling to cease ingestion of calcium supplements (\>1000 mg/d)
- Unwilling or unable to complete informed consent or study questionnaires
- Psychiatric or other clinical conditions that preclude study compliance
- Other important medical or safety considerations at the discretion of the investigator and/or study physician, including non-compliance with the study therapy or other activities
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2017
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02186015
Start Date
February 1 2015
End Date
November 9 2017
Last Update
May 14 2021
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153