Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
Breast Cancer, Hot Flashes, Hot Flushes
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring lobular breast carcinoma in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, ductal breast carcinoma in situ, hot flashes
Eligibility Criteria
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
Sites / Locations
- Center for Cancer Care at OSF Saint Anthony Medical Center
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- Commonwealth Hematology-Oncology, PC - Worcester
- Lakeland Regional Cancer Care Center - St. Joseph
- Kingsbury Center for Cancer Care at Cheshire Medical Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Wayne Memorial Hospital, Incorporated
- Kinston Medical Specialists
- FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I
Arm II
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.
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.