Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00031720
Study type	Interventional
Source	Alliance for Clinical Trials in Oncology
Contact
Status	Completed
Phase	Phase 2
Start date	March 2002
Completion date	November 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04681911` - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer	Phase 2
Terminated	`NCT04066790` - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer	Phase 2
Completed	`NCT04890327` - Web-based Family History Tool	N/A
Completed	`NCT03591848` - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility	N/A
Recruiting	`NCT03954197` - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients	N/A
Terminated	`NCT02202746` - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer	Phase 2
Active, not recruiting	`NCT01472094` - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed	`NCT06049446` - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn	`NCT06057636` - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study	N/A
Recruiting	`NCT05560334` - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations	Phase 2
Active, not recruiting	`NCT05501769` - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer	Phase 1
Recruiting	`NCT04631835` - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer	Phase 1
Completed	`NCT04307407` - Exercise in Breast Cancer Survivors	N/A
Recruiting	`NCT03544762` - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation	Phase 3
Terminated	`NCT02482389` - Study of Preoperative Boost Radiotherapy	N/A
Enrolling by invitation	`NCT00068003` - Harvesting Cells for Experimental Cancer Treatments
Completed	`NCT00226967` - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting	`NCT06019325` - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy	N/A
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms