Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Instituto Brasileiro de Controle do Cancer
Information provided by (Responsible Party):
Eduardo Carneiro de Lyra, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT00926315
First received: June 19, 2009
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients.


Condition Intervention
Breast Neoplasms
Postmenopausal Disorder
Drug: calcitriol
Drug: Calcitriol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Follow-up for 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: calcitriol
calcitriol supplementation (0.25 mcg 2x/d)
Drug: calcitriol
Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
Other Name: Rocaltrol
Drug: Calcitriol
calcitriol 0.25 mcg PO bid
Other Name: Rocaltrol

Detailed Description:

Women affected by breast cancer present lower 1,25(OH)2D3 or 25(OH)D3 serum levels than unaffected ones. Calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. Vitamin D has antiproliferative effects in breast cancer cell lines and breast cancer xenografts.

Post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). Tumor dimension and proliferation rate (as determined by Ki67 expression), 25(OH)D3 and/or 1,25(OH)2D3 serum concentration, will be evaluated before and after calcitriol supplementation. Tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women
  • Invasive breast carcinoma
  • Clinical conditions for breast surgery
  • No previous neoadjuvant treatment for breast cancer
  • Agreement to take part in the study and sign the informed consent

Exclusion Criteria:

  • History of hypercalcemia or nephrolithiasis
  • Current use of corticosteroids, vitamin D supplementation, HRT
  • Previous chemotherapy, hormonotherapy or radiotherapy
  • Parathyroid disease
  • Absence of clinical condition to receive supplementation
  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: NCT00926315

Locations
Brazil
Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, SP, Brazil, 03102-002
Sponsors and Collaborators
University of Sao Paulo General Hospital
Instituto Brasileiro de Controle do Cancer
Investigators
Study Chair: Maria Aparecida A Koike Folgueira, MD,PhD Faculdade de Medicina - Universidade de São Paulo
Principal Investigator: Eduardo Carneiro de Lyra, MD, PhD Instituto Brasileiro de Controle do Cancer
Principal Investigator: Yuri N Urata, MSc Faculdade de Medicina da Universidade de São Paulo
Principal Investigator: Maria Lucia H Katayama, PhD Faculdade de Medicina da Universidade de São Paulo
  More Information

Publications:

Responsible Party: Eduardo Carneiro de Lyra, MD, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT00926315     History of Changes
Other Study ID Numbers: FMUSPIBCCVD2009, CAPPesq 626/06, FAPESP 07/04799-2, IBCC 108/2006/07, CAPPesq 0018/09
Study First Received: June 19, 2009
Last Updated: October 31, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Breast Neoplasms
Calcitriol
Postmenopausal
Cell Proliferation
Gene Expression Profiling

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Calcitriol
Vitamin D
Vitamins
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014