Effects of Soy Compounds on Breast Cancer, Prostate Cancer, and Bone Health
Primary Purpose
Breast Cancer, Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Soy Isoflavone Nutritional Supplements
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring isoflavones, soy, postmenopausal, men, prostate, breast, bone
Eligibility Criteria
Inclusion Criteria Scheduled for prostatectomy Willing and able to consume study tablets for at least 2 weeks prior to surgery Willing to accept random assignment Signed informed consent Exclusion Criteria Unwilling to avoid soy intake during the study period Currently taking antibiotics
Sites / Locations
- Christopher Gardner
Outcomes
Primary Outcome Measures
Markers of Bone Density
Basic Science (e.g., proliferation of cancer cells in vitro)
Secondary Outcome Measures
Bioavailability
Full Information
NCT ID
NCT00200824
First Posted
September 13, 2005
Last Updated
March 10, 2009
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00200824
Brief Title
Effects of Soy Compounds on Breast Cancer, Prostate Cancer, and Bone Health
Official Title
Effects of Soy Isoflavones on the Prostate, Breast and Bone
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
This study will determine the effects of soy products on in vitro surrogate cancer markers as well as bone density markers and quality of life parameters in men and women. This study will also determine concentrations of isoflavones (naturally occurring plant compounds that act like estrogen in the body) in prostate tissue that has been removed during prostatectomy, as well as in the blood.
Detailed Description
In the United States, consumption of soy products has dramatically increased in the past several years. Foods made from soy are high in isoflavones and evidence suggests that these isoflavones, genistein in particular, have many beneficial properties such as alleviating menopausal side effects and reducing the risk of osteoporosis, breast cancer, and prostate cancer. However, this data has been derived largely from studies with animal or cell models; human trials are limited. This study will determine the effects of soy isoflavones on quality of life and cancer and bone density markers.
While isoflavones have been purported to inhibit the proliferation of cancer cells, the concentrations required for this anti-cancer effect were determined to be much higher than the concentrations that can be achieved in plasma after intake of isoflavones. Recent animal studies have suggested that isoflavones may be concentrated 10-fold in tissue compared to blood concentrations. If this is true, then the higher concentration would be in the range found in the cancer cell line research to be protective of cancer. This study will determine whether tissue concentrations are similar to, higher than, or different than blood concentrations.
This study will last 5 years and will comprise three populations: men with prostate cancer on androgen ablation therapy, postmenopausal women on hormone replacement therapy (HRT), and postmenopausal women not on HRT. Participants will be randomly assigned to receive either isoflavone or placebo for two to four weeks. Participants' serum and serum extracts will be incubated with cultured human cell lines (prostate cancer, breast cancer and osteoblasts) and estrogenic and non-estrogenic mechanisms of action investigated. The human sera data will be complemented by parallel studies of direct addition of crystalline isoflavones (genistein, daidzein and equol) to the same cultured human cell lines. Participant's serum and urine also will be tested for markers of bone resorption and formation. Quality of life issues will be assessed with questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer
Keywords
isoflavones, soy, postmenopausal, men, prostate, breast, bone
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Soy Isoflavone Nutritional Supplements
Primary Outcome Measure Information:
Title
Markers of Bone Density
Title
Basic Science (e.g., proliferation of cancer cells in vitro)
Secondary Outcome Measure Information:
Title
Bioavailability
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Scheduled for prostatectomy
Willing and able to consume study tablets for at least 2 weeks prior to surgery
Willing to accept random assignment
Signed informed consent
Exclusion Criteria
Unwilling to avoid soy intake during the study period
Currently taking antibiotics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Gardner
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christopher Gardner
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Soy Compounds on Breast Cancer, Prostate Cancer, and Bone Health
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