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

NCT01816555 | Terminated Phase 1 DMC

• 1 other identifier: 101813
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II

Outcome Measures

Primary Outcomes (1)

• Compare the differences in the T cell phenotype and function using PBMCs from patients in different cohorts

  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.

  Prior to Treatment (Baseline), Week 4 and Week 8

Study Arms (2)

Vitamin D- Normal Level at Screening

EXPERIMENTAL

Subjects will have surgery as their initial breast therapy. If subjects have a normal level of Vitamin D(25-hydroxyVit D 30-100ng/mL), they will be assigned to this group.

Dietary Supplement: Vitamin D

Vitamin D- Insufficient or Deficient Level at Screening

EXPERIMENTAL

Subjects will have surgery as their initial breast therapy. If subjects are insufficient (25-hydroxy Vit D 21-29 ng/mL)or deficient (25-hydroxyVit D \<20ng/mL) Vitamin D levels, they will be assigned to this group.

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Subjects will be assigned to a dosage level between 600IU daily and 10,000IU daily depending on their age, weight and current vitamin D level

Vitamin D- Insufficient or Deficient Level at Screening; Vitamin D- Normal Level at Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be greater than or equal to 18 years of age.
• Patients must have a newly diagnosed invasive ductal breast carcinoma, Stage I-II.
• Patients who have completed their surgical and radiation therapy.
• Patients must have SWOG performance status of 0, 1 or 2.
• Patients must have adequate organ function as defined by:
• Hgb \> 8.0 gm/dl, WBC \> 3,500, platelet count \> 100,000
• Bilirubin \< 2.0 mg/dl, SGOT \< 4x upper limit of normal
• Creatinine \< 2.0 mg/dl or calculated creatinine clearance \> 50 ml/min
• Patients must have a serum calcium - phosphate product that is less than 70.
• Patients must have recovered from any prior surgery.
• Patients must be willing to use appropriate contraception if of child-bearing potential.
• Patients may be on standard of care maintenance dose Vit D3

You may not qualify if:

• Patients with histology of lobular carcinoma.
• Patients with metastatic disease.
• Pregnant or lactating women.
• Male gender.
• Patients with a history of sarcoidosis.
• Patients with any history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions.
• Patients who have received any of the following treatments within the last 14 days prior to study registration will be excluded.
• Lithium
• Digitalis
• Thiazide diuretics
• Calcium supplementation during 1,25-dihydroxyvitamin D3 treatment
• Bisphosphonates
• Teriparatide
• Aluminum Hydroxide
• Bile Acid sequestrants

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: March 22, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 22, 2015

Record last verified: 2014-08

Locations

US (1)