Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UCLH-BCRG-DIETCOMPLYF-1456 | |||
| EU-20823 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene expression analysis | Genetic | |||
| polymorphism analysis | Genetic | |||
| high performance liquid chromatography | Other | |||
| laboratory biomarker analysis | Other | |||
| mass spectrometry | Other | |||
| questionnaire administration | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed invasive primary breast cancer
Completed active treatment for primary breast cancer within 9 months to 15 months after diagnosis
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anthony Leathem, MD | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Hospital | Recruiting | London | England | NW1 2BU | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| D002851 | Chromatography, High Pressure Liquid |
| D013058 | Mass Spectrometry |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016172 | DNA Fingerprinting |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D002853 | Chromatography, Liquid |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
Not provided
Not provided