Breast Cancer Clinical Trial
Official title:
Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen
Verified date | July 2016 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 112 |
Est. completion date | November 2013 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Eligibility 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene | New Hampshire |
United States | Kinston Medical Specialists | Kinston | North Carolina |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst | North Carolina |
United States | Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford | Illinois |
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 | Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph | Michigan |
United States | Commonwealth Hematology-Oncology, PC - Worcester | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI), Protein Technologies International |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in number of daily hot flushes at 3 months from baseline | Up to 3 months | No | |
Primary | Change in hot-flush score at 3 months from baseline | Up to 3 months | No |
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