Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036686
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2002-05-13
Brief Title:
Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Clinical Trial of the Action of Isoflavones in Breast Neoplasia Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Eating a diet rich in soy foods may slow the progression of some types of cancer Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells and prevent further development of breast cancer
PURPOSE Randomized pilot trial to study the effectiveness of isoflavones in preventing further development of breast cancer in women who are planning to undergo mastectomy or lumpectomy
PURPOSE Randomized pilot trial to study the effectiveness of isoflavones in preventing further development of breast cancer in women who are planning to undergo mastectomy or lumpectomy
Detailed Description:
OBJECTIVES
Determine the effect of soy protein isolate isoflavones on modulation of intermediate endpoint biomarkers such as cell proliferation apoptosis and steroid hormones in women planning to undergo mastectomy or lumpectomy for breast cancer
Determine the effect of soy protein isolate on serum isoflavone levels in these patients
Correlate changes in serum isoflavones with changes in cell proliferation apoptosis and hormonal levels in patients treated with this therapy
Correlate the changes in cell proliferation and apoptosis with hormonal markers in patients treated with this therapy
OUTLINE This is a randomized placebo-controlled double-blind study Patients are stratified according to the phase of the menstrual cycle at time of biopsy and time of surgery follicular phase ie during first 7 days of menstrual cycle vs luteal phase ie after day 7 of the menstrual cycle Patients are randomized to one of two treatment arms
Arm I Patients receive oral soy protein isolate twice daily and oral multivitamins once daily
Arm IIPatients receive oral placebo twice daily and oral multivitamins once daily
In both arms treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure
PROJECTED ACCRUAL A total of 106 patients 53 per treatment arm will be accrued for this study within 18 months
Determine the effect of soy protein isolate isoflavones on modulation of intermediate endpoint biomarkers such as cell proliferation apoptosis and steroid hormones in women planning to undergo mastectomy or lumpectomy for breast cancer
Determine the effect of soy protein isolate on serum isoflavone levels in these patients
Correlate changes in serum isoflavones with changes in cell proliferation apoptosis and hormonal levels in patients treated with this therapy
Correlate the changes in cell proliferation and apoptosis with hormonal markers in patients treated with this therapy
OUTLINE This is a randomized placebo-controlled double-blind study Patients are stratified according to the phase of the menstrual cycle at time of biopsy and time of surgery follicular phase ie during first 7 days of menstrual cycle vs luteal phase ie after day 7 of the menstrual cycle Patients are randomized to one of two treatment arms
Arm I Patients receive oral soy protein isolate twice daily and oral multivitamins once daily
Arm IIPatients receive oral placebo twice daily and oral multivitamins once daily
In both arms treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure
PROJECTED ACCRUAL A total of 106 patients 53 per treatment arm will be accrued for this study within 18 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0104 | OTHER | CCOP | None |
| NCI-5348 | OTHER | None | None |
| NCI-P02-0214 | OTHER | None | None |