Modulation of Postmenopausal Steroid Hormone Levels by Phytoestrogens and Correlation with Breast Proliferative Activity and Menopausal Symptoms
Abstract
To evaluate the effect of a phytoestrogen supplement on steroid hormones and their target tissues, 60 disease-free postmenopausal breast cancer survivors are being randomized to either 1OOmg/d isoflavone tablets or placebo for one year. Hormone levels are measured at baseline 6 months, and one year. Changes in menopausal symptoms, vaginal maturation, and breast epithelial proliferation are also being measured. The trial was opened to accrual in June 2001. As of June 2002, 631 breast cancer patients had been screened through the Seattle Cancer Care Alliance. We received 56 additional self or clinician referrals. from both groups 467 were found to be ineligible 52 refused participation. The number one reason for ineligibility at our institution is stage (75%). Of the eight women who stated their primary reason for refusal. The most common reasons have been complaints of invasiveness of the trial (15%) and unwillingness to take phytoestrogen supplements (31%) . In order to increase recruitment yield, a mechanism to see patients who receive their oncologic care outside the sponsoring institution was developed and community outreach campaign begun. In the past month, 4 more women have been randomized. We expect to have full data on 8 subjects and mid-intervention data on at least 6 subjects by the time of the next annual report.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2002
- Accession Number
- ADA410800
Entities
People
- Julie R. Gralow
- Melanie R. Palomares
Organizations
- University of Washington