Back to results

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

Primary Purpose

Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional treatment trial for Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Vitamin D- Normal Level at Screening

Vitamin D- Insufficient or Deficient Level at Screening

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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- 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01816555

First Posted

February 6, 2013

Last Updated

July 20, 2015

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT01816555

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Terminated

Why Stopped

Study closed due to low accrual.

Study Start Date

January 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D- Normal Level at Screening

Arm Type

Experimental

Arm Description

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.

Arm Title

Vitamin D- Insufficient or Deficient Level at Screening

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs