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

NCT ID: NCT01816555

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

101813

Identifier Type: -

Identifier Source: org_study_id