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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00691509
First received: June 4, 2008
Last updated: August 23, 2013
Last verified: June 2008
  Purpose

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

Study Type: Observational
Official Title: The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Survival

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Relapse-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 2300
Study Start Date: January 2005
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691509

Locations
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
Investigators
Principal Investigator: Anthony Leathem, MD University College London Hospitals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00691509     History of Changes
Other Study ID Numbers: CDR0000589004, UCLH-BCRG-DIETCOMPLYF-1456, EU-20823
Study First Received: June 4, 2008
Last Updated: August 23, 2013
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Physiological Effects of Drugs
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014