Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Closed Postmenopausal (20 and over) NCI CALGB-79805 NCI-P02-0206, NCT00031720

Objectives

1. 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.
2. Compare the quality of life in patients treated with these regimens.
3. Compare the time to first relief of hot flashes in patients treated with these regimens.
4. Compare the effect of these regimens on hormonal change in these patients.

Entry 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

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

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

Expected Enrollment

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

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Gini Fleming, MD, Protocol chair		Ph: 773-702-6712; 888-824-0200 Email: gfleming@medicine.bsd.uchicago.edu

Registry Information
Official Title		Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen
Trial Start Date		2002-03-15
Registered in ClinicalTrials.gov		NCT00031720
Date Submitted to PDQ		2002-01-09
Information Last Verified		2008-12-08
NCI Grant/Contract Number		CA76001