Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

October 31, 2012 updated by: Eduardo Carneiro de Lyra, University of Sao Paulo General Hospital

Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 03102-002
        • Instituto Brasileiro De Controle Do Câncer - IBCC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Rocaltrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Follow-up for 5 years
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

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 Sao Paulo
  • Principal Investigator: Maria Lucia H Katayama, PhD, Faculdade de Medicina da Universidade de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (ESTIMATE)

June 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMUSPIBCCVD2009
  • CAPPesq 626/06 (REGISTRY: Comissão Ética para Análise Projetos Pesquisa HCFMUSP 626/06)
  • FAPESP 07/04799-2 (OTHER_GRANT: Fundação de Amparo à Pesquisa Estado de São Paulo 07/04799-2)
  • IBCC 108/2006/07 (REGISTRY: Comitê de Ética em Pesquisa IBCC 108/2006/07)
  • CAPPesq 0018/09 (REGISTRY: Comissão Ética para Análise Projetos Pesquisa HCFMUSP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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