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NCT02186015 · ClinicalTrials.gov registry record · Phase 2
Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D)
A Phase 2 study of Metastatic Breast Cancer and Estrogen Receptor Positive, sponsored by Loyola University.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT02186015 is a Phase 2 study of Metastatic Breast Cancer and Estrogen Receptor Positive that has completed, run by Loyola University. The registered enrollment target is 43 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02186015, a Phase 2 study of Metastatic Breast Cancer and Estrogen Receptor Positive, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study 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 associated with treatment for estrogen receptor positive (ER+) breast cancer, specifically aromatase inhibitors (AIs.) Presumably for generalizability and potential safety purposes, these trials predominantly exclude women with metastatic breast cancer (MBC); a rapidly expanding sector of the cancer survivor population who experience significant treatment-related side-effects. Evaluation of the safety of vitamin D3 supplementation is crucial since supplementation can lead to high calcium and importantly, in lab studies have shown that vitamin D3 affects a gene that increases estrogen production. To assure that vitamin D3 does not affect the clinical effects of anti-estrogen therapies, the effect of vitamin D3 supplements on estrogen production requires an evaluation that further explores and defines its potential role in symptom management for this population. Objectives: This pilot study will evaluate the feasibility of vitamin D3 supplementation in women with MBC, providing much needed data on the preliminary safety and efficacy of this treatment in this patient population. This study will determine: 1) if weekly supplementation of high dose vitamin D3 increases serum vitamin D levels without adverse effects related to such therapy (primary aim); 2) the effects of vitamin D3 supplementation on symptom management (secondary aim); and 3) if vitamin D3 supplementation is associated with improved inflammation (exploratory aim.) Methods: This is an 8 week "proof of concept" study to monitor laboratory parameters and to assess potential effects on short-term outcomes. Adult, female patients (\>=18 years) with ER+ MBC (Stage IV) of any race/ethnicity and a history of vitamin D \< 30 mg/dl will be recruited from within and around LUMC. Following current clinical practice guidelines,
Conditions Studied
Interventions
- DRUG Cholecalciferol
Study Locations (1)
Illinois
- Loyola University Medical Center - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-02 |
| Est. Completion | 2017-11-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02186015
The ClinicalTrials.gov registry entry for NCT02186015 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (79% lower). The listed sponsor is Loyola University, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Cholecalciferol is the first listed.
NCT02186015 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT02186015 about?
NCT02186015 is a clinical study titled "Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D)". 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 associated with treatment for estrogen receptor positive (ER+) breast cancer, specifically aromatase inhibito...
What is the current status of trial NCT02186015?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2015-02. Estimated completion is 2017-11-09.
What conditions does trial NCT02186015 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Estrogen Receptor Positive, Adult Women.
What interventions are being tested in trial NCT02186015?
The interventions under investigation include: Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT02186015?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02186015 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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