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Breast Cancer Research and Treatment

, Volume 134, Issue 2, pp 759–767 | Cite as

Feasibility of a randomized controlled trial of vitamin D vs. placebo in women with recently diagnosed breast cancer

  • David W. Cescon
  • Patricia A. Ganz
  • Samantha Beddows
  • Marguerite Ennis
  • Barbara K. Mills
  • Pamela J. GoodwinEmail author
Clinical Trial

Abstract

Low serum vitamin D levels have been associated with poor outcomes in women diagnosed with early breast cancer. However, no randomized controlled trials (RCTs) have been performed to determine whether vitamin D supplementation might be an effective intervention in this population. We prospectively evaluated vitamin D adequacy and supplementation rates in a contemporary cross-sectional sample of breast cancer patients from 2 large urban centers and examined the feasibility of an RCT of vitamin D supplementation. Women with recently diagnosed early breast cancer were prospectively identified and recruited in Toronto and Los Angeles between March 2009 and January 2010. Anthropometric measurements, dietary, lifestyle, and medication histories were obtained by means of structured questionnaires and interviews. Tumor and treatment characteristics were abstracted from clinical records and blood samples were collected for analysis of 25-OH vitamin D. 173 eligible patients (median age 57) were enrolled. Clinical and treatment characteristics were similar between centres. 84.4 % of women reported use of vitamin D-containing supplements with median daily doses of 1,400 IU. Median 25-OH vitamin D levels were 85.5 and 98.5 nmol/L (P = 0.1), and levels of deficiency (<50 nmol/L), insufficiency (50–72 nmol/L), and adequacy (>72 nmol/L) were 3.8, 23.8, 72.5 % (Toronto) and 4.3, 20.7, 75 % (Los Angeles). 25-OH vitamin D levels were strongly correlated with vitamin D supplement use (r = 0.41, P < 0.0001). 68 % of women expressed willingness to participate in a vitamin D supplementation RCT; however, only 12.7 % of the study population met the pre-specified feasibility criteria (25-OH vitamin D <72 nmol/L, willing to participate, and taking ≤1,000 IU vitamin D supplement/day). Both vitamin D levels and supplementation rates are higher than in previous reports. While the majority of women would be willing to participate in an RCT of vitamin D supplementation, low levels of deficiency/insufficiency and high rates of supplement use would limit the feasibility of such a study.

Keywords

Breast cancer Vitamin D Adjuvant therapy Randomized controlled trials Outcomes 

Notes

Acknowledgments

This work was funded by the Breast Cancer Research Foundation. David Cescon is supported by a CAMO-CIHR Fellowship.

Conflict of interest

None.

Ethical standards

This study complies with the current laws of the countries in which they were performed.

Supplementary material

10549_2012_2120_MOESM1_ESM.docx (87 kb)
Supplementary material 1 (DOCX 88 kb)

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Copyright information

© Springer Science+Business Media, LLC. 2012

Authors and Affiliations

  • David W. Cescon
    • 1
    • 2
  • Patricia A. Ganz
    • 3
    • 4
  • Samantha Beddows
    • 1
  • Marguerite Ennis
    • 5
  • Barbara K. Mills
    • 4
  • Pamela J. Goodwin
    • 1
    • 2
    Email author
  1. 1.Mount Sinai HospitalTorontoCanada
  2. 2.Division of Medical Oncology and HematologyUniversity of TorontoTorontoCanada
  3. 3.UCLA School of Public HealthLos AngelesUSA
  4. 4.Jonsson Comprehensive Cancer CenterLos AngelesUSA
  5. 5.MarkhamCanada

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