Dietary Phytoestrogens, Complementary and Alternative Medicine, and Lifestyle in Predicting Survival of Women With Breast Cancer
NCT ID: NCT00691509
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2300 participants
OBSERVATIONAL
2005-01-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Interventions
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gene expression analysis
polymorphism analysis
high performance liquid chromatography
laboratory biomarker analysis
mass spectrometry
questionnaire administration
Eligibility Criteria
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Inclusion Criteria
* 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
75 Years
FEMALE
No
Sponsors
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University College London Hospitals
OTHER
Principal Investigators
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Anthony Leathem, MD
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
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University College Hospital
London, England, United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Other Identifiers
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UCLH-BCRG-DIETCOMPLYF-1456
Identifier Type: -
Identifier Source: secondary_id
EU-20823
Identifier Type: -
Identifier Source: secondary_id
CDR0000589004
Identifier Type: -
Identifier Source: org_study_id