Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
18 Years
N/A
Female
Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
Trial Information
Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Compare the differences in the T cell phenotype and function using PBMCs from patients in different cohorts
Outcome Description:
T cell analysis for the following markers will be evaluated- memory markers activation status and presence of regulatory T cells lymphoid organ-homing receptors Functional status of gated T cells will be analyzed 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.
Outcome Time Frame:
Prior to Treatment (Baseline), Week 4 and Week 8
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
101813
NCT ID:
NCT01816555
Start Date:
January 2013
Completion Date:
Related Keywords:
- Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
- Breast Neoplasms
- Carcinoma
- Carcinoma, Ductal, Breast
Name | Location |
|---|---|
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
