NCT00200824

Brief Summary

This study will determine the effects of soy products on in vitro surrogate cancer markers as well as bone density markers and quality of life parameters in men and women. This study will also determine concentrations of isoflavones (naturally occurring plant compounds that act like estrogen in the body) in prostate tissue that has been removed during prostatectomy, as well as in the blood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2000

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

March 12, 2009

Status Verified

August 1, 2006

First QC Date

September 13, 2005

Last Update Submit

March 10, 2009

Conditions

Breast CancerProstate Cancer

Keywords

isoflavonessoypostmenopausalmenprostatebreastbone

Outcome Measures

Primary Outcomes (2)

  • Markers of Bone Density

  • Basic Science (e.g., proliferation of cancer cells in vitro)

Secondary Outcomes (1)

  • Bioavailability

Interventions

Soy Isoflavone Nutritional SupplementsDRUG

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for prostatectomy
  • Willing and able to consume study tablets for at least 2 weeks prior to surgery
  • Willing to accept random assignment
  • Signed informed consent

You may not qualify if:

  • Unwilling to avoid soy intake during the study period
  • Currently taking antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christopher Gardner

Stanford, California, 94305-5705, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Christopher Gardner

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

May 1, 2000

Study Completion

January 1, 2005

Last Updated

March 12, 2009

Record last verified: 2006-08

Locations

US(1)