Trial Information

The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Survival

OBJECTIVES:

- 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.