Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
NCT ID: NCT00031720
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2002-03-31
2013-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
soy protein
Given orally
isoflavones
Given orally
Tamoxifen
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.
Tamoxifen
Placebo
Oral
Interventions
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soy protein
Given orally
isoflavones
Given orally
Tamoxifen
Placebo
Oral
Eligibility Criteria
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Inclusion Criteria
1. 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.
2. Current daily tamoxifen use. Any planned surgery, adjuvant chemotherapy or radiation must have been completed.
3. 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.
4. Postmenopausal status: surgical menopause, no menses for ≥ 1 year or postmenopausal FSH levels.
5. 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.
6. 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.
7. No concurrent systemic hormone replacement therapy or use of vaginal estrogen creams. Use of the estradiol releasing vaginal ring (Estring®) is allowed.
8. No history of soy or milk intolerance
9. CALGB performance status 0-2
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Protein Technologies International
UNKNOWN
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Gini F. Fleming, MD
Role: STUDY_CHAIR
University of Chicago
Locations
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Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Commonwealth Hematology-Oncology, PC - Worcester
Worcester, Massachusetts, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
Countries
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Other Identifiers
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CALGB-79805
Identifier Type: -
Identifier Source: secondary_id
NCI-P02-0206
Identifier Type: -
Identifier Source: secondary_id
CDR0000069219
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-79805
Identifier Type: -
Identifier Source: org_study_id
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