- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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
- 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:
- 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
- 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
- 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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Rockford, Illinois, United States, 61108
- Center for Cancer Care at OSF Saint Anthony Medical Center
-
-
Indiana
-
Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
-
Kokomo, Indiana, United States, 46904
- Howard Community Hospital
-
La Porte, Indiana, United States, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
-
South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
-
South Bend, Indiana, United States, 46617
- Saint Joseph Regional Medical Center
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- Commonwealth Hematology-Oncology, PC - Worcester
-
-
Michigan
-
St. Joseph, Michigan, United States, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
-
-
New Hampshire
-
Keene, New Hampshire, United States, 03431
- Kingsbury Center for Cancer Care at Cheshire Medical Center
-
Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
North Carolina
-
Goldsboro, North Carolina, United States, 27534
- Wayne Memorial Hospital, Incorporated
-
Kinston, North Carolina, United States, 28501
- Kinston Medical Specialists
-
Pinehurst, North Carolina, United States, 28374
- FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Eligibility Criteria:
- Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast stages I-III A.
- Current daily tamoxifen use. Any planned surgery, adjuvant chemotherapy or radiation must have been completed.
- History of bothersome hot flushes: ≥ 7 hot flushes/day, sufficiently severe that intervention is desired. Participants must have had bothersome hot flushes for at least one month prior to enrollment.
- Postmenopausal status: surgical menopause, no menses for ≥ 1 year or postmenopausal FSH levels.
No concurrent use of vitamin E, progestins (Megace® or others), clonidine, belladonna derivative or commercially available soy supplement preparations for treatment of hot flushes. Participants must have at least a 4-week washout period prior to day 1 of run-in if any of these have been used.
Participants may be taking low doses of vitamin E that are part of a multivitamin.
- Concurrent use of anti-depressant, such as Paxil® , Prozac®, or Effexor® is allowed if the participant has been on a stable dose for more than a month and the purpose of the medication is for other than control of hot flushes. If SSRI's are used for hot flashes, they must be discontinued for 4 weeks prior to day 1 of run-in.
- No concurrent systemic hormone replacement therapy or use of vaginal estrogen creams. Use of the estradiol releasing vaginal ring (Estring®) is allowed.
- No history of soy or milk intolerance
- CALGB performance status 0-2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
All patients receive placebo for 7 days as part of the run-in period.
Patients being treated with tamoxifen were randomized to treatment arm I and received 40 gm soy protein and 90 mg isoflavones daily for 12 weeks.
|
Given orally
Given orally
|
Placebo Comparator: Arm II
All patients receive placebo for a 7 day run in period.
Patients being treated with tamoxifen randomized to Arm II received placebo daily for 12 weeks.
|
Oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in number of daily hot flushes at 3 months from baseline
Time Frame: Up to 3 months
|
Up to 3 months
|
Change in hot-flush score at 3 months from baseline
Time Frame: Up to 3 months
|
Up to 3 months
|
Collaborators and Investigators
Investigators
- Study Chair: Gini F. Fleming, MD, University of Chicago
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Hot Flashes
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
Other Study ID Numbers
- CALGB-79805
- U10CA076001 (U.S. NIH Grant/Contract)
- NCI-P02-0206
- CDR0000069219 (Registry Identifier: NCI Physicians Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on Tamoxifen
-
Institut Cancerologie de l'OuestActive, not recruiting
-
Seoul National University HospitalRecruitingHormone Receptor-positive Breast Cancer | Premenopausal Breast CancerKorea, Republic of
-
Northwestern UniversityNational Cancer Institute (NCI)CompletedEstrogen Receptor-positive Breast Cancer | Ductal Breast Carcinoma in SituUnited States
-
European Institute of OncologyIstituto Oncologico Veneto IRCCS; Ente Ospedaliero Ospedali Galliera; Istituto...Not yet recruitingDuctal Carcinoma in Situ | RAD51C Gene Mutation | RAD51D Gene Mutation | PALB2 Gene Mutation | Lobular Carcinoma in Situ | ATM Gene Mutation | CDH1 Gene Mutation | CHEK2 Gene Mutation | BRCA MutationItaly
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedBreast Cancer | Stage IV Breast CancerUnited States, Canada, Peru
-
National Cancer Center, KoreaUnknown
-
Northwestern UniversityNational Cancer Institute (NCI); BHR Pharma, LLCRecruitingEstrogen Receptor Positive | Ductal Breast Carcinoma In SituUnited States
-
The Methodist Hospital Research InstituteMillennium Pharmaceuticals, Inc.CompletedEstrogen Receptor Positive Breast CancerUnited States
-
Kafrelsheikh UniversityNot yet recruiting
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Breast Carcinoma | Stage IV Breast Cancer AJCC v6 and v7 | Stage III Breast Cancer AJCC v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7United States