Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200824
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2005-09-13
Brief Title:
Effects of Soy Compounds on Breast Cancer Prostate Cancer and Bone Health
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Effects of Soy Isoflavones on the Prostate Breast and Bone
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Participants serum and urine also will be tested for markers of bone resorption and formation Quality of life issues will be assessed with questionnaires
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 Participants serum and urine also will be tested for markers of bone resorption and formation Quality of life issues will be assessed with questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None