3 weeks of Vitamin D can not help much (Breast Cancer surgery in this case) – RCT

Randomized window of opportunity trial evaluating high-dose vitamin D in breast cancer patients.

Breast Cancer Res Treat. 2019 Aug 9. doi: 10.1007/s10549-019-05392-9.

The body probably only had a few days to make use of a good level of vitamin D (reached 94 ng) A loading dose (get all of the vitamin D in 1-7 days) would get a similar level in 1 week. But it is doubtful than the extra week would help much 1. Overview Breast Cancer and Vitamin D contains the following {include} --- * Vitamin D reduced Breast Cancer mortality in 9 out of 9 studies, yet still no consensus – April 2019 - Having a good level of vitamin D increases chance of survival * Chemotherapy for Breast Cancer lowers Vitamin D levels – Oct 2018 * Breast Cancer chemotherapy 2.7 X more likely to be successful if not vitamin D deficient – Dec 2017 * Vitamin D prevents breast cancer, reduces BC mortality, and reduces BC chemotherapy problems – Sept 2018 * Perhaps Breast Cancer tumors can be reduced by 7 weeks of 50,000 IU Vitamin D – 2023 * Vitamin D could reduce the need for surgery

Arnaout A1,2, Robertson S3, Pond GR4, Vieth R5, Jeong A2, Hilton J2,6, Ramsey T7, Clemons M8,9.

1 Division of Surgical Oncology, Department of Surgery, Ottawa Hospital, Ottawa, Canada.

2 Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.

3 Division of Anatomical Pathology, Ottawa Hospital, Ottawa, Canada.

4 Department of Oncology, McMaster University, Hamilton, Canada.

5 Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Canada.

6 Division of Medical Oncology, Department of Medicine, University of Ottawa and Ottawa Hospital Cancer Center, Ottawa, ON, Canada.

7 Center for Practice Changing Research, Ottawa Hospital Research Institute, Ottawa, Canada.

8 Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada. mclemons@toh.ca.

9 Division of Medical Oncology, Department of Medicine, U. of Ottawa and Ottawa Hospital Cancer Center, Ottawa, mclemons@toh.ca.

PURPOSE:

Epidemiologic and preclinical data suggest a potential role for vitamin D in breast cancer treatment and prevention. However, results of prospective randomized trials are inconsistent. The objective of this study was to assess the effects of high-dose cholecalciferol (vitamin D3) on breast tumour proliferation and apoptosis.

METHODS:

We conducted a prospective, randomized, phase 2, double-blinded pre-surgical window of opportunity trial. Newly diagnosed breast cancer patients were randomized to receive 40,000 IU of vitamin D3 per day or placebo for 2 to 6 weeks prior to breast surgery. The primary outcome was the relative change in proliferation (Ki67) and apoptosis (cleaved caspase 3 apoptotic assay [CC3]) in primary breast cancer cells pre and post treatment.

RESULTS:

Of 83 patients randomized, 80 completed the study (43 (53.8%) vitamin D and 37 (46.3%) placebo). Mean duration of drug intake was 19 days (range 9-28 days). There were no significant differences between the control arm and the vitamin D arm in percent changes of either Ki67 index (1.6% vs. 16.7%, p = 0.25) or CC3 (- 55.9% vs. - 45.9%, p = 0.28). Serum 25-hydroxyvitamin D (25-OHD) levels were 3 times higher in the vitamin D arm (62 nmol/L vs. 246 nmol/L, p < 0.001). Adverse effects were minimal and all classified as grade 1.

CONCLUSIONS:

Despite significantly higher levels of serum 25-OHD in the vitamin D-treated group, this was not associated with any significant effects on tumour proliferation or apoptosis. These findings are consistent with the lack of benefit observed in prospective prevention trials.