Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | December 2008 |
| End Date: | December 2009 |
Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women.
The purpose of the study is to evaluate whether hCG will result in a decrease in breast
density.
High breast density has been associated with an increased risk in breast cancer. It has also
been shown that decreasing density with a drug called tamoxifen has resulted in a decreased
risk in breast cancer. The investigators are looking at the effect of hCG on breast density
in people who are at increased risk of developing breast cancer and our theory postulates
that through the hormonal actions of hCG and tamoxifen there would be a greater reduction in
breast density in patients who are treated with hCG and tamoxifen versus patients treated
with tamoxifen alone. Using this data the investigators will be able to hypothesize that the
treatment of hCG will result in a reduction in breast cancer rates in the population and
thus make available another drug which can be used to decrease the rates of breast cancer in
the population
density.
High breast density has been associated with an increased risk in breast cancer. It has also
been shown that decreasing density with a drug called tamoxifen has resulted in a decreased
risk in breast cancer. The investigators are looking at the effect of hCG on breast density
in people who are at increased risk of developing breast cancer and our theory postulates
that through the hormonal actions of hCG and tamoxifen there would be a greater reduction in
breast density in patients who are treated with hCG and tamoxifen versus patients treated
with tamoxifen alone. Using this data the investigators will be able to hypothesize that the
treatment of hCG will result in a reduction in breast cancer rates in the population and
thus make available another drug which can be used to decrease the rates of breast cancer in
the population
Pregnancy has been associated with a decreased risk of breast cancer. This has been
reproduced in multiple studies and has been seen in multiple races.
People have been evaluating different hormones and practices associated with pregnancy to
determine what factors reduce the risk of developing breast cancer in these patients. These
pronounced findings have been evaluated in great detail by multiple scientists and one of
the hormones which we think might be associated with a reduction in breast cancer is hCG.
This statement has been backed by multiple studies which have looked at the direct effect of
hCG on the growth and death of breast cancer cells in the lab and in animal models of breast
cancer.
We want to determine if hCG is given to patients who are at increased risk of breast cancer
will result in an accentuated decrease in breast cancer risk above and beyond the effect
received by conventional breast cancer reducing protocols. Our final outcome in this study
will be breast density on mammographic evaluation which is considered a marker for breast
cancer. So our study will evaluate whether or not hCG will have an effect on the
mammographic breast density.
After recruitment there will be two groups in our study an intervention group and non
intervention group. In the intervention group patients would undergo a period of hCG
injections which would last a total of 60 days and consist of 30 subcutaneous injections.
The non intervention group will continue their conventional chemoprevention medication. Both
groups will be followed for teo years and the images, cytology and blood samples will be
sent to our labs for evaluation.
reproduced in multiple studies and has been seen in multiple races.
People have been evaluating different hormones and practices associated with pregnancy to
determine what factors reduce the risk of developing breast cancer in these patients. These
pronounced findings have been evaluated in great detail by multiple scientists and one of
the hormones which we think might be associated with a reduction in breast cancer is hCG.
This statement has been backed by multiple studies which have looked at the direct effect of
hCG on the growth and death of breast cancer cells in the lab and in animal models of breast
cancer.
We want to determine if hCG is given to patients who are at increased risk of breast cancer
will result in an accentuated decrease in breast cancer risk above and beyond the effect
received by conventional breast cancer reducing protocols. Our final outcome in this study
will be breast density on mammographic evaluation which is considered a marker for breast
cancer. So our study will evaluate whether or not hCG will have an effect on the
mammographic breast density.
After recruitment there will be two groups in our study an intervention group and non
intervention group. In the intervention group patients would undergo a period of hCG
injections which would last a total of 60 days and consist of 30 subcutaneous injections.
The non intervention group will continue their conventional chemoprevention medication. Both
groups will be followed for teo years and the images, cytology and blood samples will be
sent to our labs for evaluation.
Inclusion Criteria:
- On tamoxifen therapy for the treatment or prevention of breast cancer.
- Must have at least one remaining breast.
Exclusion Criteria:
- Pregnant or nursing.
- No history of allergic reactions to hCG.
- Patients who have had bilateral mastectomies.
- Uncontrolled thyroid disease.
- Cognitively impaired and unable to consent for the trial.
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