Clinical Trial: Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II

Brief Summary: This study is for adult females who have been newly diagnosed with breast cancer that includes surgery as part of standard cancer treatment. This is a research study combining Vitamin D (an over the counter medication) with the standard of care (or the established and approved treatment), surgery. Evidence shows that women who are Vitamin D3 deficient have a higher risk of breast cancer and breast cancer recurrence. The purpose of this study is to find out the effects of Vitamin D3 during the treatment period for Stage I-II breast cancer. Screening tests will be done to determine if subjects are eligible to participate in this study. If subjects are eligible and they agree to participate, they will be assigned to one of two groups which will receive different amounts of vitamin D. Subjects will be asked to keep a medication diary. Subjects may remain on treatment for approximately 56 days.

Detailed Summary:
Sponsor: Medical University of South Carolina

Current Primary Outcome: Compare the differences in the T cell phenotype and function using PBMCs from patients in different cohorts [ Time Frame: Prior to Treatment (Baseline), Week 4 and Week 8 ]

T cell analysis for the following markers will be evaluated-

  1. memory markers
  2. activation status and presence of regulatory T cells
  3. lymphoid organ-homing receptors
  4. Functional status of gated T cells will be analyzed
  5. cell surface thiol molecules and intracellular glutathione using flow cytometry to evaluate if anti-oxidant stus of the T cells is modulated in presence of the Vitamin D.

These markers will help in determining the immunomodulatory potential of Vitamin D on T cell with respect to function, activation status and anti-oxidant capacity that can effect persistence and in turn immune outcome. The data obtained will be reported in terms of percent increase or decrease in number of T cells expressing particular receptors (homing or chemokine) or for differences in functional outcome (cytokine response) upon activation relative to samples collected at baseline.



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medical University of South Carolina

Dates:
Date Received: February 6, 2013
Date Started: January 2013
Date Completion:
Last Updated: July 20, 2015
Last Verified: August 2014