Vitamin D and Breast Cancer: Does Weight Make a Difference?

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Melinda Telli, Stanford University
ClinicalTrials.gov Identifier:
NCT01472445
First received: November 11, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

This is a research study of the effect of Vitamin D on breast cancer. We hope to learn whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that affect its growth. We believe some of these characteristics may be influenced by body weight.


Condition Intervention
Breast Cancer
Drug: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Vitamin D and Breast Cancer: Does Weight Make a Difference?

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Measurement of gene expression at the mRNA (Messenger Ribonucleic acid) level using PCR (polymerase chain reaction) arrays [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3, Supportive care, A
Vitamin D 10,000 IU/day
Drug: Vitamin D3
Vitamin D 10,000 IU/day
Other Name: cholecalciferol
Experimental: Vitamin D3, Supportive Care, B
Vitamin D 400 IU/day
Drug: Vitamin D3
Vitamin D 400 IU/day
Other Name: cholecalciferol

Detailed Description:

This protocol is a randomized, controlled and blinded clinical trial in obese and non-obese subjects diagnosed with breast cancer in whom we will test the effects of vitamin D supplementation in the neoadjuvant setting and evaluate changes in biomarker expression in blood and tissue comparing core breast biopsy to definitive surgical samples. Our goal is to determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by favorable changes in the gene expression patterns in the pathologic specimens as well as in serum biomarkers of insulin resistance and adipokine secretion. We expect that vitamin D administration will improve the breast cancer gene expression pattern from a high-risk configuration to a low-risk profile in the obese patients and will also cause improvement in the non-obese.

  Eligibility

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

Inclusion Criteria:

  • 3.1.1 Women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy.
  • 3.1.2 No prior therapy for breast cancer.
  • 3.1.4 Age 18 years or older.
  • 3.1.5 Any menopausal status
  • 3.1.6 Planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy.
  • 3.1.7 Availability of tissue blocks from initial core needle biopsy.
  • 3.1.8 Signed informed consent.
  • 3.1.9 Willing to discontinue use of all supplements containing Vitamin D for the duration of the study, and take only the Vitamin D provided by the study.

Exclusion Criteria:

  • 3.2.1 Presence of any Metastatic lesion.
  • 3.2.2 History of parathyroid disease, hypercalcemia, or kidney stones.
  • 3.2.3 History of SERM or aromatase inhibitor therapy.
  • 3.2.4 Taking metformin.
  • 3.2.5 History of renal failure requiring dialysis or kidney transplantation.
  • 3.2.6 Women who are known to be pregnant or who are nursing. (As vitamin D does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
  • 3.2.7 Patients planned for surgical therapy of their breast cancer or initiation of systemic chemotherapy, that would not allow for at least 7 days of vitamin D intervention
  • 3.2.9 Any condition potentially interfering with subjects ability to comply with taking study medication.
  • 3.2.10 Any medical condition that would potentially interfere with vitamin D absorption.
  • 3.2.11 Current participation in another research study that would increase risk to subject, in the opinion of the investigators.
  • 3.2.12 Patients currently taking more than 2000 IU of Vitamin D.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472445

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Annabel Castaneda    650-498-7977    annabelc@stanford.edu   
Sub-Investigator: David Feldman, MD         
Sub-Investigator: Kristin Jensen, MD         
Sponsors and Collaborators
Melinda Telli
Investigators
Principal Investigator: Melinda Telli, MD Stanford University
  More Information

No publications provided

Responsible Party: Melinda Telli, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01472445     History of Changes
Other Study ID Numbers: BRSADJ0024, SU-09262011-8486, 21034, 21034
Study First Received: November 11, 2011
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Vitamin D
Obesity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 27, 2014