Trial record 15 of 91 for:    Open Studies | "Carcinoma, Ductal, Breast"

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

This study is currently recruiting participants.
Verified March 2013 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Megan Baker, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01816555
First received: February 6, 2013
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D- Normal Level at Screening
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
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
Experimental: Vitamin D- Insufficient or Deficient Level at Screening
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Repletion dose VitD3 in setting of known Vit D3 deficiency or insufficiency
  • Patients who have received concurrent corticosteroid treatments within the last 14 days prior to study registration will be excluded.
  • Known HIV positive.
  • Patients with an active infection requiring antibiotic therapy.
  • Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  • Patients undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01816555

Contacts
Contact: Megan K Baker Ruppel, MD 843-876-0179 bakermk@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Megan K Baker Ruppel, MD    843-876-0179    bakermk@musc.edu   
Sub-Investigator: Shikhar Mehrotra, PhD         
Sub-Investigator: Rita Kramer, MD         
Sub-Investigator: Frank Brescia, MD         
Sub-Investigator: Neal Christiansen, MD         
Sub-Investigator: David Cole, MD         
Sub-Investigator: Mark Lockett, MD         
Sponsors and Collaborators
Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Megan Baker, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01816555     History of Changes
Other Study ID Numbers: 101813
Study First Received: February 6, 2013
Last Updated: March 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Ductal, Breast
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 14, 2014