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Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen

Phase 2
20 Years
Not Enrolling
Breast Cancer, Hot Flashes

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Trial Information

Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen


- 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

- 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.

Inclusion Criteria


- 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



- 20 and over


- 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


- Not specified


- Not specified


- Not specified


- No prior soy or milk intolerance


Biologic therapy:

- Not specified


- 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


- Prior radiotherapy allowed

- No concurrent radiotherapy


- Prior surgery allowed

- No concurrent surgery


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Change in number of daily hot flashes at 3 months from baseline

Principal Investigator

Gini F. Fleming, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

March 2002

Completion Date:

April 2006

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • 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
  • Breast Neoplasms
  • Hot Flashes



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