Dietary Phytoestrogens, Complementary and Alternative Medicine, and Lifestyle in Predicting Survival of Women With Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
gene expression analysis
polymorphism analysis
high performance liquid chromatography
laboratory biomarker analysis
mass spectrometry
questionnaire administration
Sponsored by
About this trial
This is an observational trial for Breast Cancer focused on measuring breast cancer
Eligibility 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
Sites / Locations
- University College HospitalRecruiting
Outcomes
Primary Outcome Measures
Relapse-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00691509
First Posted
June 4, 2008
Last Updated
August 23, 2013
Sponsor
University College London Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT00691509
Brief Title
Dietary Phytoestrogens, Complementary and Alternative Medicine, and Lifestyle in Predicting Survival of Women With Breast Cancer
Official Title
The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Survival
Study Type
Observational
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University College London Hospitals
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer
7. Study Design
Enrollment
2300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
high performance liquid chromatography
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
mass spectrometry
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Relapse-free survival
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Leathem, MD
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-207-679-9396
Email
a.leathem@ucl.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Dietary Phytoestrogens, Complementary and Alternative Medicine, and Lifestyle in Predicting Survival of Women With Breast Cancer
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