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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00691509
• Other study ID #: CDR0000589004
• Secondary ID: UCLH-BCRG-DIETCO
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2008
• Last updated: August 23, 2013
• Start date: January 2005

Study information

• Verified date: June 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• gene expression analysis

• polymorphism analysis

Other:
• high performance liquid chromatography

• laboratory biomarker analysis

• mass spectrometry

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	University College Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival			No