NCT00691509

Brief Summary

RATIONALE: Eating a diet rich in phytoestrogens may slow the growth of breast cancer cells and prevent further tumor progression. Learning about the lifestyles of women with breast cancer, their intake of phytoestrogens derived from food and supplements, and their use of complementary or alternative medicine (CAM) practices may help doctors learn more about breast cancer. PURPOSE: This clinical trial is studying the effect of dietary and supplemental phytoestrogens and CAM therapies in preventing progression and improving survival of women with breast cancer.

Trial Health

55
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Trial Health Score

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

Enrollment
2,300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

August 26, 2013

Status Verified

June 1, 2008

Enrollment Period

5.9 years

First QC Date

June 4, 2008

Last Update Submit

August 23, 2013

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Relapse-free survival

Interventions

gene expression analysisGENETIC
polymorphism analysisGENETIC
high performance liquid chromatographyOTHER
laboratory biomarker analysisOTHER
mass spectrometryOTHER
questionnaire administrationOTHER

Eligibility Criteria

AgeUp to 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed invasive primary breast cancer * Grade I to III disease * No bilateral disease * Completed active treatment for primary breast cancer within 9 months to 15 months after diagnosis * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * No prior cancer except basal cell carcinoma * No other concurrent primary cancer * No cognitive impairment * No psychological problems (e.g., severe endogenous depression) * Able to understand English well PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University College Hospital

London, England, NW1 2BU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gene Expression ProfilingAmplified Fragment Length Polymorphism AnalysisChromatography, High Pressure LiquidMass Spectrometry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification TechniquesChromatography, LiquidChromatographyChemistry Techniques, Analytical

Study Officials

  • Anthony Leathem, MD

    University College London Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 5, 2008

Study Start

January 1, 2005

Primary Completion

December 1, 2010

Last Updated

August 26, 2013

Record last verified: 2008-06

Locations

GB(1)