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Dietary Phytoestrogens, Complementary and Alternative Medicine, and Lifestyle in Predicting Survival of Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00691509
Recruitment Status : Unknown
Verified June 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : June 5, 2008
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment
Breast Cancer Genetic: gene expression analysis Genetic: polymorphism analysis Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry Other: questionnaire administration

Detailed Description:


  • To determine if phytoestrogen intake affects breast cancer progression and survival in women with breast cancer.
  • To consider the influence of other phytochemicals on breast cancer progression in these patients, using samples of patient blood and urine and patient-derived data.
  • To develop a database of food, dietary supplements, and phytoestrogens based on data derived from these patients.
  • To consider influences of diet and dietary supplements on quality of life of these patients.
  • To measure 17 phytoestrogens in blood and urine samples from these patients.

OUTLINE: This is a multicenter study.

Patients undergo blood and urine sample collection once a year for 5 years during routine clinical follow-up after breast cancer diagnosis and treatment. Blood samples are frozen for future analysis of body hormones, tumor markers, and immune reactions, as well as vitamins and plant chemicals reflecting patient diet and supplements. Blood samples are also analyzed for genetic studies of cancer risk factors and polymorphisms. Urine samples are analyzed for the presence of phytoestrogens and their metabolites by immunoassays, high performance liquid chromatography (HPLC), and mass spectrometry. Some samples are analyzed for estrogenic potency by the estrogen receptor-mediated chemical activated luciferase gene expression test to assess total plasma levels of estrogen-mimics not previously detected by the other tests. Phytochemicals are also assessed.

Patients also complete a series of questionnaires once each year for 5 years and an EPIC 7-day Food Diary in years 2 and 4 to assess the role of diet and lifestyle in breast cancer survival. The questionnaires include the EORTC Quality of Life-30 to assess lifestyle; the General Health Questionnaire 12 to assess general health and levels of anxiety; and up to two Food Frequency questionnaires to assess habitual dietary intake of phytoestrogens. Patients are also asked about their use of dietary supplements and complementary and alternative medicine.

Study Type : Observational
Estimated Enrollment : 2300 participants
Official Title: The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Survival
Study Start Date : January 2005
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Relapse-free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691509

United Kingdom
University College Hospital Recruiting
London, England, United Kingdom, NW1 2BU
Contact: Contact Person    44-207-679-9396    a.leathem@ucl.ac.uk   
Sponsors and Collaborators
University College London Hospitals
Principal Investigator: Anthony Leathem, MD University College London Hospitals

ClinicalTrials.gov Identifier: NCT00691509     History of Changes
Other Study ID Numbers: CDR0000589004
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: June 2008

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases