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

RATIONALE: Soy protein supplement may be effective in reducing hot flashes 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 flashes in postmenopausal women who are receiving tamoxifen for breast disease such as ductal hyperplasia or breast cancer.

Condition	Intervention	Phase
Breast Cancer Breast Cancer in Situ Hot Flashes	Drug: soy protein isolate  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: dietary modification  Procedure: herbal medicine / botanical therapy  Procedure: hot flashes attenuation  Procedure: menopausal symptoms attenuation  Procedure: nutritional supplementation  Procedure: phytoestrogen therapy  Procedure: supportive care/therapy	Phase II

Further study details as provided by National Cancer Institute (NCI):

OBJECTIVES:

• Compare the effect of soy protein vs placebo on the daily number and severity of hot flashes in postmenopausal women with breast disease taking tamoxifen.
• Compare the quality of life in patients treated with these regimens.
• Compare the time to first relief of hot flashes in patients treated with these regimens.
• Compare the effect of these regimens on hormonal change in these patients.

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).

Patients receive oral placebo once per day and keep a hot flash diary daily for 1 week and are then randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral soy supplement once daily for 12 weeks.
• Arm II: Patients receive oral placebo once daily for 12 weeks. Patients on both arms complete a daily hot flash diary.

Quality of life is assessed at baseline and at weeks 6 and 12.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 130 patients (65 per treatment arm) will be accrued for this study within 9 months.

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast disease, including one of the following:
• Atypical ductal hyperplasia
• Ductal carcinoma in situ
• Lobular carcinoma in situ
• Stage I, II, or IIIA invasive adenocarcinoma
• Must be taking tamoxifen on a daily basis
• Bothersome hot flashes, at least 7 per day for at least 1 month and severe enough to make patient desire intervention
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS:

Age:

• 20 and over

Sex:

• Female

Menopausal status:

• Postmenopausal, defined by one of the following:
• Surgical menopause
• At least 1 year since prior menses
• Postmenopausal FSH levels

Performance status:

• CALGB 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No prior soy or milk intolerance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior adjuvant chemotherapy allowed
• No concurrent adjuvant chemotherapy

Endocrine therapy:

• See Disease Characteristics
• At least 4 weeks since prior progestational therapy
• No concurrent progestins (e.g., megestrol)
• No concurrent systemic hormone replacement therapy or vaginal estrogen creams
• Estradiol-releasing vaginal ring allowed

Radiotherapy:

• Prior radiotherapy allowed
• No concurrent radiotherapy

Surgery:

• Prior surgery allowed
• No concurrent surgery

Other:

• At least 4 weeks since prior vitamin E, clonidine, belladonna derivative, or soy supplement for hot flashes
• At least 4 weeks since prior selective serotonin reuptake inhibitors for hot flashes
• Concurrent antidepressants allowed provided dose has been stable for at least 1 month and the purpose is for other than control of hot flashes
• No concurrent vitamin E, clonidine, belladonna derivative, or other soy supplement for hot flashes
• Concurrent low doses of vitamin E that are part of a multivitamin allowed
• No other concurrent soy products

Please refer to this study by ClinicalTrials.gov identifier  NCT00031720

California
      El Camino Hospital, Mountain View,  California,  94040,  United States; Recruiting
Delaware
      Beebe Medical Center, Lewes,  Delaware,  19958,  United States; Recruiting
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19718,  United States; Recruiting
      St. Francis Hospital, Wilmington,  Delaware,  19805,  United States; Recruiting
District of Columbia
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Illinois
      Center for Cancer Care at OSF Saint Anthony Medical Center, Rockford,  Illinois,  61108,  United States; Recruiting
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Maine
      Central Maine Medical Center, Lewiston,  Maine,  04240,  United States; Recruiting
Maryland
      Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore,  Maryland,  21201-1595,  United States; Recruiting
      Union Hospital Cancer Center at Union Hospital, Elkton MD,  Maryland,  21921,  United States; Recruiting
Michigan
      Battle Creek Health System Cancer Care Center, Battle Creek,  Michigan,  49017,  United States; Recruiting
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      Hackley Hospital, Muskegon,  Michigan,  49443,  United States; Recruiting
      Holland Community Hospital, Holland,  Michigan,  49423,  United States; Recruiting
      Lacks Cancer Center at Saint Mary's Mercy Medical Center, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      Mecosta County General Hospital, Big Rapids,  Michigan,  49307,  United States; Recruiting
      Metropolitan Hospital, Grand Rapids,  Michigan,  49506,  United States; Recruiting
      Munson Medical Center, Traverse City,  Michigan,  49684,  United States; Recruiting
      Northern Michigan Hospital, Petoskey,  Michigan,  49770,  United States; Recruiting
      Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Missouri
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
      Saint Luke's Hospital, Chesterfield,  Missouri,  63017,  United States; Recruiting
Nebraska
      Great Plains Regional Medical Center, North Platte,  Nebraska,  69103,  United States; Recruiting
      Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center, Grand Island,  Nebraska,  68803,  United States; Recruiting
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198,  United States; Recruiting
Nevada
      CCOP - Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
      University Medical Center of Southern Nevada, Las Vegas,  Nevada,  89102,  United States; Recruiting
New Hampshire
      Frisbie Memorial Hospital, Rochester,  New Hampshire,  03867,  United States; Recruiting
      Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene,  New Hampshire,  03431,  United States; Recruiting
      New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett,  New Hampshire,  03106,  United States; Recruiting
      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees, Camden,  New Jersey,  08103,  United States; Recruiting
New York
      Cancer Care Center at Catskill Regional Medical Center, Harris,  New York,  12742,  United States; Recruiting
      CCOP - Hematology-Oncology Associates of Central New York, Syracuse,  New York,  13057,  United States; Recruiting
      Community General Hospital of Greater Syracuse, Syracuse,  New York,  13215,  United States; Recruiting
      Roswell Park Cancer Institute, Buffalo,  New York,  14263,  United States; Recruiting
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157,  United States; Recruiting
      Lenoir Memorial Cancer Center, Kinston,  North Carolina,  28501,  United States; Recruiting
      Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst,  North Carolina,  28374,  United States; Recruiting
      Wayne Memorial Hospital, Incorporated, Goldsboro,  North Carolina,  27534,  United States; Recruiting
      Wayne Radiation Oncology, Goldsboro,  North Carolina,  27534,  United States; Recruiting
      Wilson Medical Center, Wilson,  North Carolina,  27893,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210,  United States; Recruiting
South Carolina
      Bon Secours St. Francis Health System, Greenville,  South Carolina,  29601,  United States; Recruiting
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
Virginia
      Danville Regional Medical Center, Danville,  Virginia,  24541,  United States; Recruiting
      Martha Jefferson Hospital Cancer Care Center, Charlottesville,  Virginia,  22901,  United States; Recruiting

Study chairs or principal investigators

Gini F. Fleming, MD,  Study Chair,  University of Chicago   

Study ID Numbers:  CDR0000069219; CALGB-79805; NCI-P02-0206
Last Updated:  January 24, 2006
Record first received:  March 8, 2002
ClinicalTrials.gov Identifier:  NCT00031720
Health Authority: United States: Federal Government