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COMPLETED Phase 2

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

NCT00031720 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00031720

The ClinicalTrials.gov registry entry for NCT00031720 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00031720 reports 14 study locations spanning 6 distinct geographic areas — top geographies include Indiana, North Carolina, New Hampshire. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00031720?

The interventions under investigation include: Placebo (OTHER), Tamoxifen (DRUG), soy protein (DIETARY_SUPPLEMENT), isoflavones (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00031720?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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