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Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031720
  Purpose

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
Cancer-Related Problem/Condition
Drug: placebo
Drug: soy protein isolate
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Breast Diseases Cancer Dietary Supplements
Drug Information available for: Tamoxifen Tamoxifen citrate Proteins, soy
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title: Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen

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

Primary Outcome Measures:
  • Change in number of daily hot flashes at 3 months from baseline
  • Change in hot-flash score at 3 months from baseline

Study Start Date: March 2002
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral soy supplement once daily for 12 weeks.
Drug: soy protein isolate
Given orally
Arm II: Placebo Comparator
Patients receive oral placebo once daily for 12 weeks.
Drug: placebo
Given orally

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031720

Locations
United States, Illinois
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
United States, Massachusetts
Commonwealth Hematology-Oncology, PC - Worcester
Worcester, Massachusetts, United States, 01605
United States, Michigan
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, New Hampshire
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Gini F. Fleming, MD University of Chicago
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069219, CALGB-79805, NCI-P02-0206
Study First Received: March 8, 2002
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00031720  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Carcinoma, Lobular
Skin Diseases
Carcinoma in Situ
Hot Flashes
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Tamoxifen
Recurrence
Breast Diseases
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009