Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D)
Status:
Completed
Trial end date:
2017-11-09
Target enrollment:
Participant gender:
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, eligible
participants will receive 50,000 IUs of vitamin D3 weekly for 8 weeks. Laboratory values,
muscle function and inflammation will be examined pre- and post-supplementation, while
symptoms will be assessed at baseline, 4 and 8 weeks post-supplementation. We will assess if
increases in vitamin D are associated with clinically significant improvements in symptoms
and QOL, and decreased inflammation.
Phase:
Phase 2
Details
Lead Sponsor:
Loyola University
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins