NCT00031720

Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease

Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Hot Flashes
• Hot Flushes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	soy protein	Given orally
DIETARY_SUPPLEMENT	isoflavones	Given orally
DRUG	Tamoxifen
OTHER	Placebo	Oral

Timeline

• Start date: 2002-03-01
• Primary completion: 2006-04-01
• Completion: 2013-11-01
• First posted: 2003-01-27
• Last updated: 2016-07-13

Locations

14 sites across 1 country: United States