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

NCT00031720 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2016-07-13

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

soy protein

Given orally

DIETARY_SUPPLEMENT

isoflavones

Given orally

DRUG

Tamoxifen

OTHER

Placebo

Oral

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Protein Technologies International

    collaborator UNKNOWN

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Gini F. Fleming, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2006-04-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00031720 on ClinicalTrials.gov