Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
RATIONALE: Soy protein supplement may be effective in reducing hot flushes in postmenopausal
 women who are receiving tamoxifen for breast disease.

 PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement
 in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast
 disease such as ductal hyperplasia or breast cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
 are stratified according to duration of hot flashes (less than 9 months vs 9 months or more)
 and frequency of hot flashes (7 to 9 per day vs more than 9 per day). For more information
 regarding the treatment regimens, please see the treatment arms section.

 Primary objectives:

 1. To compare the effect of daily soy supplementation versus placebo on the daily number of
 hot flushes experienced by postmenopausal women taking tamoxifen measured at three
 months from baseline

 2. To compare the effect of daily soy supplementation versus placebo on hot flush severity
 as measured by the average daily hot flash score in this population of women measured at
 three months from baseline

 Secondary objectives:

 1. To evaluate the effect of soy supplementation as compared to women randomized to placebo
 on quality of life as measured by the Medical Outcomes Study (MOS) sleep subscale, the
 Mental Health Inventory (MHI), the CES-D Short Form, the Menopause and Reproductive
 Health Questionnaire, and the General Quality of Life Form

 2. To measure the effect of soy supplementation as compared to women randomized to placebo
 on serum isoflavones, estradiol, SHBG, IGF1 and IGFBP3 levels as measures of hormonal
 change

 3. To estimate the effect of daily soy supplementation versus placebo on the time to first
 relief of hot flushes

 A total of 112 patients accrued on this study. Patients were followed 6 months
 post-randomization.
Eligibility Criteria:

 1. Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ
 (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast
 stages I-III A.

 2. Current daily tamoxifen use. Any planned surgery, adjuvant chemotherapy or radiation
 must have been completed.

 3. History of bothersome hot flushes: ≥ 7 hot flushes/day, sufficiently severe that
 intervention is desired. Participants must have had bothersome hot flushes for at
 least one month prior to enrollment.

 4. Postmenopausal status: surgical menopause, no menses for ≥ 1 year or postmenopausal
 FSH levels.

 5. No concurrent use of vitamin E, progestins (Megace® or others), clonidine, belladonna
 derivative or commercially available soy supplement preparations for treatment of hot
 flushes. Participants must have at least a 4-week washout period prior to day 1 of
 run-in if any of these have been used.

 Participants may be taking low doses of vitamin E that are part of a multivitamin.

 6. Concurrent use of anti-depressant, such as Paxil® , Prozac®, or Effexor® is allowed if
 the participant has been on a stable dose for more than a month and the purpose of the
 medication is for other than control of hot flushes. If SSRI's are used for hot
 flashes, they must be discontinued for 4 weeks prior to day 1 of run-in.

 7. No concurrent systemic hormone replacement therapy or use of vaginal estrogen creams.
 Use of the estradiol releasing vaginal ring (Estring®) is allowed.

 8. No history of soy or milk intolerance

 9. CALGB performance status 0-2