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NCT00031720 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Breast Cancer and Hot Flashes, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 2
Development phase
112
Enrollment target
14
Study locations

NCT00031720 is a Phase 2 study of Breast Cancer and Hot Flashes that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 112 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 14 study locations across 6 states.

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The verdict

NCT00031720, a Phase 2 study of Breast Cancer and Hot Flashes, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 2
Development phase
112 participants
Enrollment target
14
Study locations

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.

Interventions

  • OTHER Placebo
  • DRUG Tamoxifen
  • DIETARY_SUPPLEMENT soy protein
  • DIETARY_SUPPLEMENT isoflavones

Study Locations (14)

Indiana

  • Elkhart General Hospital - Elkhart
  • Howard Community Hospital - Kokomo
  • Center for Cancer Therapy at LaPorte Hospital and Health Services - La Porte
  • CCOP - Northern Indiana CR Consortium - South Bend
  • Memorial Hospital of South Bend - South Bend
  • Saint Joseph Regional Medical Center - South Bend

North Carolina

  • Wayne Memorial Hospital, Incorporated - Goldsboro
  • Kinston Medical Specialists - Kinston
  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center - Pinehurst

New Hampshire

  • Kingsbury Center for Cancer Care at Cheshire Medical Center - Keene
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center - Lebanon

Illinois

  • Center for Cancer Care at OSF Saint Anthony Medical Center - Rockford

Massachusetts

  • Commonwealth Hematology-Oncology, PC - Worcester - Worcester

Michigan

  • Lakeland Regional Cancer Care Center - St. Joseph - Saint Joseph

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2002-03
Est. Completion 2013-11
Phase Phase 2

What the Registry Record Tells You About NCT00031720

The ClinicalTrials.gov registry entry for NCT00031720 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT00031720 reports 14 study locations spanning 6 distinct geographic areas - top geographies include Indiana, North Carolina, New Hampshire.

Frequently Asked Questions

What is clinical trial NCT00031720 about?

NCT00031720 is a clinical study titled "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 rece...

What is the current status of trial NCT00031720?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2002-03. Estimated completion is 2013-11.

What conditions does trial NCT00031720 study?

This clinical trial studies the following conditions: Breast Cancer, Hot Flashes, Hot Flushes.

What interventions are being tested in trial NCT00031720?

The interventions under investigation include: Placebo (OTHER), Tamoxifen (DRUG), soy protein (DIETARY_SUPPLEMENT), isoflavones (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00031720?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00031720 being conducted?

This trial has 14 study locations across Illinois, Indiana, Massachusetts, Michigan, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.